Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
Active as of 2024-11-11 |
XML representation of the pqcmc-drug-substance-nomenclature-structure resource profile.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="pqcmc-drug-substance-nomenclature-structure"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: StructureDefinition pqcmc-drug-substance-nomenclature-structure</b></p><a name="pqcmc-drug-substance-nomenclature-structure"> </a><a name="hcpqcmc-drug-substance-nomenclature-structure"> </a><a name="pqcmc-drug-substance-nomenclature-structure-en-US"> </a><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a></th><th style="width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description & Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAABmJLR0QA/wD/AP+gvaeTAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3goXBCwdPqAP0wAAAldJREFUOMuNk0tIlFEYhp9z/vE2jHkhxXA0zJCMitrUQlq4lnSltEqCFhFG2MJFhIvIFpkEWaTQqjaWZRkp0g26URZkTpbaaOJkDqk10szoODP//7XIMUe0elcfnPd9zsfLOYplGrpRwZaqTtw3K7PtGem7Q6FoidbGgqHVy/HRb669R+56zx7eRV1L31JGxYbBtjKK93cxeqfyQHbehkZbUkK20goELEuIzEd+dHS+qz/Y8PTSif0FnGkbiwcAjHaU1+QWOptFiyCLp/LnKptpqIuXHx6rbR26kJcBX3yLgBfnd7CxwJmflpP2wUg0HIAoUUpZBmKzELGWcN8nAr6Gpu7tLU/CkwAaoKTWRSQyt89Q8w6J+oVQkKnBoblH7V0PPvUOvDYXfopE/SJmALsxnVm6LbkotrUtNowMeIrVrBcBpaMmdS0j9df7abpSuy7HWehwJdt1lhVwi/J58U5beXGAF6c3UXLycw1wdFklArBn87xdh0ZsZtArghBdAA3+OEDVubG4UEzP6x1FOWneHh2VDAHBAt80IbdXDcesNoCvs3E5AFyNSU5nbrDPZpcUEQQTFZiEVx+51fxMhhyJEAgvlriadIJZZksRuwBYMOPBbO3hePVVqgEJhFeUuFLhIPkRP6BQLIBrmMenujm/3g4zc398awIe90Zb5A1vREALqneMcYgP/xVQWlG+Ncu5vgwwlaUNx+3799rfe96u9K0JSDXcOzOTJg4B6IgmXfsygc7/Bvg9g9E58/cDVmGIBOP/zT8Bz1zqWqpbXIsd0O9hajXfL6u4BaOS6SeWAAAAAElFTkSuQmCC" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_resource.png" alt="." style="background-color: white; background-color: inherit" title="Resource" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition">SubstanceDefinition</a><a name="SubstanceDefinition"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( cmc-when-unii-required, cmc-name-isbt, cmc-structure-required, cmc-substance-structure-graphic-required )">C</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/substancedefinition.html">SubstanceDefinition</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The detailed description of a substance, typically at a level beyond what is used for prescribing</span><br/><span style="font-weight:bold">cmc-when-unii-required: </span>A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein'<br/><span style="font-weight:bold">cmc-name-isbt: </span>Name.type ISBT 128 required for blood products.<br/><span style="font-weight:bold">cmc-structure-required: </span>A structure is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'.<br/><span style="font-weight:bold">cmc-substance-structure-graphic-required: </span>A Substance Structure Graphic is required Required for Small Molecules. Equivalent to classification code equals 'Chemical'.</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.identifier">identifier</a><a name="SubstanceDefinition.identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span>..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">optional user designated identifier</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.classification" title="A controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model.
[Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]">classification</a><a name="SubstanceDefinition.classification"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Substance Type<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-substance-classification.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification">Substance Classification</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.manufacturer">manufacturer</a><a name="SubstanceDefinition.manufacturer"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-literal-reference.html" title="Literal Reference">LiteralReference</a>(<a href="StructureDefinition-cmc-organization.html">Basic Organization</a>)<a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html"> {</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html" title="When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.">b</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html">}</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The entity that creates, makes, produces or fabricates the substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.supplier">supplier</a><a name="SubstanceDefinition.supplier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span>..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-literal-reference.html" title="Literal Reference">LiteralReference</a>(<a href="StructureDefinition-cmc-organization.html">Basic Organization</a>)<a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html"> {</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html" title="When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.">b</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html">}</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">An entity that is the source for the substance. It may be different from the manufacturer</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.molecularWeight" title="The average mass of a molecule of a compound compared to ¹/₁₂ the mass of carbon 12 and calculated as the sum of the atomic weights of the constituent atoms. [Source: Merriam Webster]">molecularWeight</a><a name="SubstanceDefinition.molecularWeight"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span>..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Molecular Weight</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.molecularWeight.amount">amount</a><a name="SubstanceDefinition.molecularWeight.amount"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Quantity">Quantity</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Used to capture quantitative values for a variety of elements</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-units-of-measure.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure">Units Of Measure</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated. If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.">extensible</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.molecularWeight.amount.unit" title="The labeled unit of measure for the molecular weight. [Source: Adapted for NCI EVS C117055]">unit</a><a name="SubstanceDefinition.molecularWeight.amount.unit"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Molecular Weight UOM</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.molecularWeight.amount.code">code</a><a name="SubstanceDefinition.molecularWeight.amount.code"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Coded form of the unit</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.structure">structure</a><a name="SubstanceDefinition.structure"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span><a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( cmc-structure-representation-required )">C</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Structural information</span><br/><span style="font-weight:bold">cmc-structure-representation-required: </span>Either a file or string structure representation is required</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.structure.molecularFormula" title="Molecular Formula: An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined]
Biopolymer Sequence: TBD">molecularFormula</a><a name="SubstanceDefinition.structure.molecularFormula"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Molecular Formula | Biopolymer Sequence</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.structure.technique" title="The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.">technique</a><a name="SubstanceDefinition.structure.technique"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-codeable-concept-text-only.html" title="CodeableConcept">CodeableConceptTextOnly</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Substance Characterisation Technique</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: white; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.structure.representation">Slices for representation</a><a name="SubstanceDefinition.structure.representation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="font-style: italic">1</span><span style="font-style: italic">..</span><span style="opacity: 0.5; font-style: italic">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Impurity Structure Graphic | Impurity Structure Data File</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Closed by value:type</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1033.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> representation:All Slices<a name="SubstanceDefinition.structure.representation.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Content/Rules for all slices</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10320.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.structure.representation.type">type</a><a name="SubstanceDefinition.structure.representation.type"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The kind of structural representation (e.g. full, partial)</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-representation-types.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types">Representation Types</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1035.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.structure.representation:graphic" title="Slice graphic">representation:graphic</a><a name="SubstanceDefinition.structure.representation.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">A graphical, displayable depiction of the structure (e.g. an SVG, PNG)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.structure.representation:graphic.type">type</a><a name="SubstanceDefinition.structure.representation.type.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Graphic<br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1035010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1035000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C54273</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.structure.representation:graphic.document" title="A pictorial representation of the structure of the impurity substance.
[Source: SME Defined] Note: Refer to the 'Acceptable File Formats for
use in eCTD' Example: This is the representation of the molecule CH3OH,
or the sequence SHLVEALALVAGERG.">document</a><a name="SubstanceDefinition.structure.representation.document"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-literal-reference.html" title="Literal Reference">LiteralReference</a>(<a href="StructureDefinition-pqcmc-graphic-reference.html">Graphic Reference</a>)<a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html"> {</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html" title="When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.">b</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html">}</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Impurity Structure Graphic</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1035.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.structure.representation:structureFile" title="Slice structureFile">representation:structureFile</a><a name="SubstanceDefinition.structure.representation.4"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">machine-readable representation -- attached file<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.structure.representation:structureFile.type">type</a><a name="SubstanceDefinition.structure.representation.type.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Structure File<br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1035010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1035000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C103240</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.structure.representation:structureFile.document">document</a><a name="SubstanceDefinition.structure.representation.document.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-literal-reference.html" title="Literal Reference">LiteralReference</a>(<a href="StructureDefinition-pqcmc-structure-reference.html">Structure Data Reference</a>)<a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html"> {</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html" title="When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.">b</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html">}</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Impurity Chemical Structure Data (files, e.g. .SDF, .CIF)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1025.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.structure.representation:structureString" title="Slice structureString">representation:structureString</a><a name="SubstanceDefinition.structure.representation.5"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">machine-readable representation -- plain text<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10251.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.structure.representation:structureString.type">type</a><a name="SubstanceDefinition.structure.representation.type.4"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Structure Textual<br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck102501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1025010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1025000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C45253</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10250.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.structure.representation:structureString.representation" title="A machine-readable representation of the structure of the chemical. [Source: SME Defined]
Examples: SMILES, INCHI">representation</a><a name="SubstanceDefinition.structure.representation.representation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Impurity Chemical Structure Data (short, plain text representations, e.g. SMILES)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10240.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.structure.representation:structureString.format">format</a><a name="SubstanceDefinition.structure.representation.format"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Drug Substance Impurity Method Type<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-chemical-structure-datafile-type-terminology.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology">Chemical Structure Data File Type Terminology</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: white; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.code">Slices for code</a><a name="SubstanceDefinition.code"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="font-style: italic">1</span><span style="font-style: italic">..</span><span style="opacity: 0.5; font-style: italic">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5; font-style: italic">Codes associated with the substance</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Open by value:code.coding.system</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.code:unii" title="Slice unii: The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/]
Example: 362O9ITL9D
Note: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/">code:unii</a><a name="SubstanceDefinition.code.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">UNII</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1341.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.code:unii.code">code</a><a name="SubstanceDefinition.code.code"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The specific code</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13401.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.code:unii.code.coding">coding</a><a name="SubstanceDefinition.code.code.coding"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Code defined by a terminology system</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.code:unii.code.coding.system">system</a><a name="SubstanceDefinition.code.code.coding.system"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Identity of the terminology system</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">http://fdasis.nlm.nih.gov</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.code:uniProt" title="Slice uniProt: The UniProt ID is an index to the UniProt knowledgebase, a large resource of protein sequences and associated detailed annotation.
It is accessible at https://www.uniprot.org/">code:uniProt</a><a name="SubstanceDefinition.code.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">UniProt ID</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1241.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.code:uniProt.code">code</a><a name="SubstanceDefinition.code.code.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The specific code</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck12401.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.code:uniProt.code.coding">coding</a><a name="SubstanceDefinition.code.code.coding.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Code defined by a terminology system</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck124000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.code:uniProt.code.coding.system">system</a><a name="SubstanceDefinition.code.code.coding.system.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Identity of the terminology system</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">https://www.uniprot.org</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name" title="Substance Name is identified by its Substance Type. Substance Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined]
Examples: GSRS Preferred Term, Systematic Name, INN, USP/NF">Slices for name</a><a name="SubstanceDefinition.name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic" title="This element must be supported">S</span><a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; font-style: italic" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( cmc-name-preferred )">C</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="font-style: italic">1</span><span style="font-style: italic">..</span><span style="opacity: 0.5; font-style: italic">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Subtance Name</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Closed by value:type</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">cmc-name-preferred: </span><span style="font-style: italic">Name.preferred: at most one = true</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck133.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> name:All Slices<a name="SubstanceDefinition.name.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Content/Rules for all slices</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1330.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name.type">type</a><a name="SubstanceDefinition.name.type"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic', 'scientific, 'brand'</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-substance-name-type.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type">Substance Name Type</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1320.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name.preferred">preferred</a><a name="SubstanceDefinition.name.preferred"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">True when the name type is Substance Name</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:sys" title="Slice sys">name:sys</a><a name="SubstanceDefinition.name.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Names applicable to this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:sys.name" title="A name derived directly from the chemical structure. [Source: SME Defined]">name</a><a name="SubstanceDefinition.name.name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Systematic</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:sys.type">type</a><a name="SubstanceDefinition.name.type.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic', 'scientific, 'brand'</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C203357</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">Systematic Name</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:sys.preferred">preferred</a><a name="SubstanceDefinition.name.preferred.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">If this is the preferred name for this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:sub" title="Slice sub">name:sub</a><a name="SubstanceDefinition.name.4"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Names applicable to this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:sub.name" title="A non-branded nor registered name that meant for common use.">name</a><a name="SubstanceDefinition.name.name.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Generic</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:sub.type">type</a><a name="SubstanceDefinition.name.type.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic', 'scientific, 'brand'</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C97054</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">Generic Name</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:sub.preferred">preferred</a><a name="SubstanceDefinition.name.preferred.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">If this is the preferred name for this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:brand" title="Slice brand">name:brand</a><a name="SubstanceDefinition.name.5"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Names applicable to this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:brand.name" title="The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies.">name</a><a name="SubstanceDefinition.name.name.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Brand</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:brand.type">type</a><a name="SubstanceDefinition.name.type.4"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic', 'scientific, 'brand'</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C71898</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">Brand</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:brand.preferred">preferred</a><a name="SubstanceDefinition.name.preferred.4"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">If this is the preferred name for this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:gsrs" title="Slice gsrs">name:gsrs</a><a name="SubstanceDefinition.name.6"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Names applicable to this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:gsrs.name" title="Default display name identified within FDA Global Substance Registration System (GSRS).">name</a><a name="SubstanceDefinition.name.name.4"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">GSRS Preferred Term</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:gsrs.type">type</a><a name="SubstanceDefinition.name.type.5"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic', 'scientific, 'brand'</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C203355</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">GSRS Preferred Term</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:gsrs.preferred">preferred</a><a name="SubstanceDefinition.name.preferred.5"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">If this is the preferred name for this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:usp" title="Slice usp">name:usp</a><a name="SubstanceDefinition.name.7"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Names applicable to this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:usp.name" title="A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Pharmacopeia (USP) and excipients by the National Formulary (NF). [Source: SME Defined]">name</a><a name="SubstanceDefinition.name.name.5"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">USP-NF Established Name</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:usp.type">type</a><a name="SubstanceDefinition.name.type.6"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic', 'scientific, 'brand'</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C203358</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">USP-NF Established Name</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:usp.preferred">preferred</a><a name="SubstanceDefinition.name.preferred.6"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">If this is the preferred name for this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:cas" title="Slice cas">name:cas</a><a name="SubstanceDefinition.name.8"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Names applicable to this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:cas.name" title="Chemical Abstract Service (CAS) Registry Numbers (often referred to as CAS RNs or CAS Numbers) are used to provide identifiers for chemical substances. A CAS Registry Number itself has no inherent chemical significance but provides a way to identify a chemical substance or molecular structure when there are many possible systematic, generic, proprietary or trivial names. [Source: Adapted from CAS.org]
Example: CAS [103-90-2]">name</a><a name="SubstanceDefinition.name.name.6"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">CAS Number</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:cas.type">type</a><a name="SubstanceDefinition.name.type.7"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic', 'scientific, 'brand'</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C54682</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">CAS Number</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:cas.preferred">preferred</a><a name="SubstanceDefinition.name.preferred.7"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">If this is the preferred name for this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:inn" title="Slice inn">name:inn</a><a name="SubstanceDefinition.name.9"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Names applicable to this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:inn.name" title="International Nonproprietary Names (INN) is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. Note: International Nonproprietary Names (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients [Source: http://www.who.int/medicines/services/inn/en/] Example: Paracetamol">name</a><a name="SubstanceDefinition.name.name.7"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">INN</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:inn.type">type</a><a name="SubstanceDefinition.name.type.8"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic', 'scientific, 'brand'</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C142585</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">INN</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:inn.preferred">preferred</a><a name="SubstanceDefinition.name.preferred.8"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">If this is the preferred name for this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:usan" title="Slice usan">name:usan</a><a name="SubstanceDefinition.name.10"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Names applicable to this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:usan.name" title="A unique nonproprietary name assigned to drugs and biologics and assigned by the United States Adopted Names Council [Source: SME Defined] Example: acetaminophen">name</a><a name="SubstanceDefinition.name.name.8"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">USAN</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:usan.type">type</a><a name="SubstanceDefinition.name.type.9"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic', 'scientific, 'brand'</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C96973</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">USAN</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:usan.preferred">preferred</a><a name="SubstanceDefinition.name.preferred.9"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">If this is the preferred name for this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:iupac" title="Slice iupac">name:iupac</a><a name="SubstanceDefinition.name.11"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Names applicable to this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:iupac.name" title="A name assigned to a chemical substance according to the systematic nomenclature rules defined by the International Union of Pure and Applied Chemistry (IUPAC) [Source: SME Defined]
Example: N- (4-hydroxyphenyl)acetamide">name</a><a name="SubstanceDefinition.name.name.9"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">IUPAC Name</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:iupac.type">type</a><a name="SubstanceDefinition.name.type.10"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic', 'scientific, 'brand'</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C203356</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">IUPAC Name</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:iupac.preferred">preferred</a><a name="SubstanceDefinition.name.preferred.10"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">If this is the preferred name for this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:isbt" title="Slice isbt">name:isbt</a><a name="SubstanceDefinition.name.12"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Names applicable to this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:isbt.name" title="It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]">name</a><a name="SubstanceDefinition.name.name.10"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">ISBT-128 DIN</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:isbt.type">type</a><a name="SubstanceDefinition.name.type.11"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic', 'scientific, 'brand'</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C95517</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">ISBT-128 DIN</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:isbt.preferred">preferred</a><a name="SubstanceDefinition.name.preferred.11"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">If this is the preferred name for this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:comp" title="Slice comp">name:comp</a><a name="SubstanceDefinition.name.13"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Names applicable to this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1250.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:comp.name" title="An internal identifier assigned by the sponsor to this drug substance. [Source: SME Defined]">name</a><a name="SubstanceDefinition.name.name.11"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Company ID/Code</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1251.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:comp.type">type</a><a name="SubstanceDefinition.name.type.12"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic', 'scientific, 'brand'</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck12501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C203354</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">Company ID/Code</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1240.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.name:comp.preferred">preferred</a><a name="SubstanceDefinition.name.preferred.12"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">If this is the preferred name for this substance</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.relationship">relationship</a><a name="SubstanceDefinition.relationship"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">A link between this substance and another</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.relationship.substanceDefinition[x]">substanceDefinition[x]</a><a name="SubstanceDefinition.relationship.substanceDefinition_x_"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-literal-reference.html" title="Literal Reference">LiteralReference</a>(<a href="StructureDefinition-pqcmc-polymorphic-form.html">Polymorphic Form</a>)<a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html"> {</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html" title="When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.">b</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html">}</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The substance definition of a polyphorm of the Drug Substance</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.relationship.type">type</a><a name="SubstanceDefinition.relationship.type"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-codeable-concept-text-only.html" title="CodeableConcept">CodeableConceptTextOnly</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Polymorph</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure-definitions.html#SubstanceDefinition.relationship.type.text">text</a><a name="SubstanceDefinition.relationship.type.text"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Plain text representation of the concept</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">Polymorph</span></td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<url
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.36.42.25"/>
</identifier>
<version value="1.0.0"/>
<name value="DrugSubstanceNomenclatureStructure"/>
<title value="Substance General Information"/>
<status value="active"/>
<date value="2024-11-11T21:40:01+00:00"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
<contact>
<name value="HL7 International / Biomedical Research and Regulation"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/rcrim"/>
</telecom>
<telecom>
<system value="email"/>
<value value="brr@lists.HL7.org"/>
</telecom>
</contact>
<description
value="Substance General Information containing Drug Substance (Active Ingredient) nomenclature (3.2.S.1.1) and Substance Structure (3.2.S.1.2) profile."/>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="US"/>
<display value="United States of America"/>
</coding>
</jurisdiction>
<fhirVersion value="5.0.0"/>
<mapping>
<identity value="w5"/>
<uri value="http://hl7.org/fhir/fivews"/>
<name value="FiveWs Pattern Mapping"/>
</mapping>
<mapping>
<identity value="idmp-substance"/>
<uri value="https://www.iso.org/obp/ui/#iso:std:iso:11238"/>
<name value="IDMP Mapping (Substance)"/>
</mapping>
<mapping>
<identity value="rim"/>
<uri value="http://hl7.org/v3"/>
<name value="RIM Mapping"/>
</mapping>
<kind value="resource"/>
<abstract value="false"/>
<type value="SubstanceDefinition"/>
<baseDefinition
value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"/>
<derivation value="constraint"/>
<snapshot>
<element id="SubstanceDefinition">
<path value="SubstanceDefinition"/>
<short
value="The detailed description of a substance, typically at a level beyond what is used for prescribing"/>
<definition
value="The detailed description of a substance, typically at a level beyond what is used for prescribing."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="SubstanceDefinition"/>
<min value="0"/>
<max value="*"/>
</base>
<constraint>
<key value="dom-2"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
<expression value="contained.contained.empty()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-3"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource"/>
<expression
value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-4"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
<expression
value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-5"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
<expression value="contained.meta.security.empty()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
<valueMarkdown
value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
</extension>
<key value="dom-6"/>
<severity value="warning"/>
<human
value="A resource should have narrative for robust management"/>
<expression value="text.`div`.exists()"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="cmc-when-unii-required"/>
<severity value="error"/>
<human
value="A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein'"/>
<expression
value="(classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists()
implies code.where(
code.coding.exists(system = 'http://fdasis.nlm.nih.gov')
).exists())
and (classification.coding.where(
system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and
code = 'C17021'
).exists() implies code.where(
code.coding.exists(system = 'https://www.uniprot.org')
).exists())"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure"/>
</constraint>
<constraint>
<key value="cmc-name-isbt"/>
<severity value="error"/>
<human value="Name.type ISBT 128 required for blood products."/>
<expression
value="classification.where(coding.where(code = '8' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy')"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure"/>
</constraint>
<constraint>
<key value="cmc-structure-required"/>
<severity value="error"/>
<human
value="A structure is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'."/>
<expression
value="classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803' |'C17021') ).exists() implies structure.exists()"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure"/>
</constraint>
<constraint>
<key value="cmc-substance-structure-graphic-required"/>
<severity value="error"/>
<human
value="A Substance Structure Graphic is required Required for Small Molecules. Equivalent to classification code equals 'Chemical'."/>
<expression
value="(classification.where(coding.where(code = '1' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists()) implies structure.representation.exists()"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="Entity, Role, or Act"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="administrative.medication"/>
</mapping>
<mapping>
<identity value="idmp-substance"/>
<map
value="Substance (and derived classes: Chemical, Polymer, Protein, Nucleic_Acid, Structurally_Diverse)"/>
</mapping>
</element>
<element id="SubstanceDefinition.id">
<path value="SubstanceDefinition.id"/>
<short value="Logical id of this artifact"/>
<definition
value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/>
<comment
value="Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="id"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="SubstanceDefinition.meta">
<path value="SubstanceDefinition.meta"/>
<short value="Metadata about the resource"/>
<definition
value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.meta"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Meta"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="SubstanceDefinition.implicitRules">
<path value="SubstanceDefinition.implicitRules"/>
<short value="A set of rules under which this content was created"/>
<definition
value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/>
<comment
value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.implicitRules"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="true"/>
<isModifierReason
value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation"/>
<isSummary value="true"/>
</element>
<element id="SubstanceDefinition.language">
<path value="SubstanceDefinition.language"/>
<short value="Language of the resource content"/>
<definition
value="The base language in which the resource is written."/>
<comment
value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.language"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="Language"/>
</extension>
<strength value="required"/>
<description value="IETF language tag for a human language"/>
<valueSet value="http://hl7.org/fhir/ValueSet/all-languages|5.0.0"/>
<additional>
<purpose value="starter"/>
<valueSet value="http://hl7.org/fhir/ValueSet/languages"/>
</additional>
</binding>
</element>
<element id="SubstanceDefinition.text">
<path value="SubstanceDefinition.text"/>
<short value="Text summary of the resource, for human interpretation"/>
<definition
value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/>
<comment
value="Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later."/>
<alias value="narrative"/>
<alias value="html"/>
<alias value="xhtml"/>
<alias value="display"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.text"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Narrative"/>
</type>
<condition value="dom-6"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="Act.text?"/>
</mapping>
</element>
<element id="SubstanceDefinition.contained">
<path value="SubstanceDefinition.contained"/>
<short value="Contained, inline Resources"/>
<definition
value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning."/>
<comment
value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels."/>
<alias value="inline resources"/>
<alias value="anonymous resources"/>
<alias value="contained resources"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.contained"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Resource"/>
</type>
<condition value="dom-2"/>
<condition value="dom-4"/>
<condition value="dom-3"/>
<condition value="dom-5"/>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="SubstanceDefinition.extension">
<path value="SubstanceDefinition.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="SubstanceDefinition.modifierExtension">
<path value="SubstanceDefinition.modifierExtension"/>
<short value="Extensions that cannot be ignored"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="SubstanceDefinition.identifier">
<path value="SubstanceDefinition.identifier"/>
<short value="optional user designated identifier"/>
<definition value="Identifier by which this substance is known."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.identifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Identifier"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Substance.Substance_Id"/>
</mapping>
</element>
<element id="SubstanceDefinition.version">
<path value="SubstanceDefinition.version"/>
<short value="A business level version identifier of the substance"/>
<definition
value="A business level version identifier of the substance."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.version"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Version.Version_Number"/>
</mapping>
</element>
<element id="SubstanceDefinition.status">
<path value="SubstanceDefinition.status"/>
<short
value="Status of substance within the catalogue e.g. active, retired"/>
<definition
value="Status of substance within the catalogue e.g. active, retired."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.status"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="PublicationStatus"/>
</extension>
<strength value="preferred"/>
<description value="The lifecycle status of an artifact."/>
<valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.classification">
<path value="SubstanceDefinition.classification"/>
<short value="Substance Type"/>
<definition
value="A controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model.
[Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.classification"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map
value="Substance_Classification.Substance_Classification and Substance_classification.Substance_Classification_Subtype"/>
</mapping>
</element>
<element id="SubstanceDefinition.domain">
<path value="SubstanceDefinition.domain"/>
<short value="If the substance applies to human or veterinary use"/>
<definition
value="If the substance applies to human or veterinary use."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.domain"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="MedicinalProductType"/>
</extension>
<strength value="example"/>
<description
value="Applicable domain for this product (e.g. human, veterinary)."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/medicinal-product-domain"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map
value="Substance_Classification.Substance_Classification (and Code and Type) and Substance_Classification.Substance_Classification_Subtype"/>
</mapping>
</element>
<element id="SubstanceDefinition.grade">
<path value="SubstanceDefinition.grade"/>
<short
value="The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)"/>
<definition
value="The quality standard, established benchmark, to which substance complies (e.g. USP/NF, Ph. Eur, JP, BP, Company Standard)."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="SubstanceDefinition.grade"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceGrade"/>
</extension>
<strength value="example"/>
<description
value="The quality standard, established benchmark, to which a substance complies"/>
<valueSet value="http://hl7.org/fhir/ValueSet/substance-grade"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="Substance_Specified_Substance_Group_3.Grade"/>
</mapping>
</element>
<element id="SubstanceDefinition.description">
<path value="SubstanceDefinition.description"/>
<short value="Textual description of the substance"/>
<definition value="Textual description of the substance."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.description"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Substance.Comment"/>
</mapping>
</element>
<element id="SubstanceDefinition.informationSource">
<path value="SubstanceDefinition.informationSource"/>
<short value="Supporting literature"/>
<definition value="Supporting literature."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="SubstanceDefinition.informationSource"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Citation"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Substance.Reference_Source"/>
</mapping>
</element>
<element id="SubstanceDefinition.note">
<path value="SubstanceDefinition.note"/>
<short
value="Textual comment about the substance's catalogue or registry record"/>
<definition
value="Textual comment about the substance's catalogue or registry record."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="SubstanceDefinition.note"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Annotation"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.manufacturer">
<path value="SubstanceDefinition.manufacturer"/>
<short
value="The entity that creates, makes, produces or fabricates the substance"/>
<definition
value="The entity that creates, makes, produces or fabricates the substance. This is a set of potential manufacturers but is not necessarily comprehensive."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.manufacturer"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
<targetProfile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
<aggregation value="bundled"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.supplier">
<path value="SubstanceDefinition.supplier"/>
<short
value="An entity that is the source for the substance. It may be different from the manufacturer"/>
<definition
value="An entity that is the source for the substance. It may be different from the manufacturer. Supplier is synonymous to a distributor."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.supplier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
<targetProfile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
<aggregation value="bundled"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.moiety">
<path value="SubstanceDefinition.moiety"/>
<short value="Moiety, for structural modifications"/>
<definition value="Moiety, for structural modifications."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="SubstanceDefinition.moiety"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Substance.Moiety"/>
</mapping>
</element>
<element id="SubstanceDefinition.moiety.id">
<path value="SubstanceDefinition.moiety.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.moiety.extension">
<path value="SubstanceDefinition.moiety.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.moiety.modifierExtension">
<path value="SubstanceDefinition.moiety.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="SubstanceDefinition.moiety.role">
<path value="SubstanceDefinition.moiety.role"/>
<short value="Role that the moiety is playing"/>
<definition value="Role that the moiety is playing."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.moiety.role"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Moiety.Moiety_Role"/>
</mapping>
</element>
<element id="SubstanceDefinition.moiety.identifier">
<path value="SubstanceDefinition.moiety.identifier"/>
<short value="Identifier by which this moiety substance is known"/>
<definition
value="Identifier by which this moiety substance is known."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.moiety.identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Identifier"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Moiety.Moiety_Id"/>
</mapping>
</element>
<element id="SubstanceDefinition.moiety.name">
<path value="SubstanceDefinition.moiety.name"/>
<short value="Textual name for this moiety substance"/>
<definition value="Textual name for this moiety substance."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.moiety.name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Moiety.Moiety_Name"/>
</mapping>
</element>
<element id="SubstanceDefinition.moiety.stereochemistry">
<path value="SubstanceDefinition.moiety.stereochemistry"/>
<short value="Stereochemistry type"/>
<definition value="Stereochemistry type."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.moiety.stereochemistry"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceStereochemistry"/>
</extension>
<strength value="example"/>
<description value="The optical rotation type of a substance."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/substance-stereochemistry"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="Moiety.Stereochemistry"/>
</mapping>
</element>
<element id="SubstanceDefinition.moiety.opticalActivity">
<path value="SubstanceDefinition.moiety.opticalActivity"/>
<short value="Optical activity type"/>
<definition value="Optical activity type."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.moiety.opticalActivity"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceOpticalActivity"/>
</extension>
<strength value="example"/>
<description value="The optical rotation type of a substance."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/substance-optical-activity"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="Moiety.Optical_Activity"/>
</mapping>
</element>
<element id="SubstanceDefinition.moiety.molecularFormula">
<path value="SubstanceDefinition.moiety.molecularFormula"/>
<short
value="Molecular formula for this moiety (e.g. with the Hill system)"/>
<definition
value="Molecular formula for this moiety of this substance, typically using the Hill system."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.moiety.molecularFormula"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Moiety.Molecular_Formula"/>
</mapping>
</element>
<element id="SubstanceDefinition.moiety.amount[x]">
<path value="SubstanceDefinition.moiety.amount[x]"/>
<short value="Quantitative value for this moiety"/>
<definition value="Quantitative value for this moiety."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.moiety.amount[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Quantity"/>
</type>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Moiety.Amount"/>
</mapping>
</element>
<element id="SubstanceDefinition.moiety.measurementType">
<path value="SubstanceDefinition.moiety.measurementType"/>
<short value="The measurement type of the quantitative value"/>
<definition
value="The measurement type of the quantitative value. In capturing the actual relative amounts of substances or molecular fragments it may be necessary to indicate whether the amount refers to, for example, a mole ratio or weight ratio."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.moiety.measurementType"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceAmountType"/>
</extension>
<strength value="example"/>
<description value="The relationship between two substance types."/>
<valueSet value="http://hl7.org/fhir/ValueSet/substance-amount-type"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="Amount.Amount_Type"/>
</mapping>
</element>
<element id="SubstanceDefinition.characterization">
<path value="SubstanceDefinition.characterization"/>
<short value="General specifications for this substance"/>
<definition value="General specifications for this substance."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="SubstanceDefinition.characterization"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.characterization.id">
<path value="SubstanceDefinition.characterization.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.characterization.extension">
<path value="SubstanceDefinition.characterization.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.characterization.modifierExtension">
<path value="SubstanceDefinition.characterization.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="SubstanceDefinition.characterization.technique">
<path value="SubstanceDefinition.characterization.technique"/>
<short value="The method used to find the characterization e.g. HPLC"/>
<definition
value="The method used to elucidate the characterization of the drug substance. Example: HPLC."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.characterization.technique"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceStructureTechnique"/>
</extension>
<strength value="example"/>
<description
value="The method used to elucidate the characterization of the drug substance."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/substance-structure-technique"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.characterization.form">
<path value="SubstanceDefinition.characterization.form"/>
<short
value="Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form"/>
<definition
value="Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.characterization.form"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceForm"/>
</extension>
<strength value="example"/>
<valueSet value="http://hl7.org/fhir/ValueSet/substance-form"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.characterization.description">
<path value="SubstanceDefinition.characterization.description"/>
<short
value="The description or justification in support of the interpretation of the data file"/>
<definition
value="The description or justification in support of the interpretation of the data file."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.characterization.description"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.characterization.file">
<path value="SubstanceDefinition.characterization.file"/>
<short
value="The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis"/>
<definition
value="The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="SubstanceDefinition.characterization.file"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Attachment"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.property">
<path value="SubstanceDefinition.property"/>
<short value="General specifications for this substance"/>
<definition value="General specifications for this substance."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="SubstanceDefinition.property"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Substance.Property"/>
</mapping>
</element>
<element id="SubstanceDefinition.property.id">
<path value="SubstanceDefinition.property.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.property.extension">
<path value="SubstanceDefinition.property.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.property.modifierExtension">
<path value="SubstanceDefinition.property.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="SubstanceDefinition.property.type">
<path value="SubstanceDefinition.property.type"/>
<short value="A code expressing the type of property"/>
<definition value="A code expressing the type of property."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.property.type"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SNOMEDCTCharacteristicCodes"/>
</extension>
<strength value="example"/>
<description
value="This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/product-characteristic-codes"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="Property.Property_Type"/>
</mapping>
</element>
<element id="SubstanceDefinition.property.value[x]">
<path value="SubstanceDefinition.property.value[x]"/>
<short value="A value for the property"/>
<definition value="A value for the property."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.property.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<type>
<code value="Quantity"/>
</type>
<type>
<code value="date"/>
</type>
<type>
<code value="boolean"/>
</type>
<type>
<code value="Attachment"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Physical Characteristics, attribute's value"/>
</mapping>
</element>
<element id="SubstanceDefinition.referenceInformation">
<path value="SubstanceDefinition.referenceInformation"/>
<short value="General information detailing this substance"/>
<definition value="General information detailing this substance."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.referenceInformation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/SubstanceReferenceInformation"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Reference_Information"/>
</mapping>
</element>
<element id="SubstanceDefinition.molecularWeight">
<path value="SubstanceDefinition.molecularWeight"/>
<short value="Molecular Weight"/>
<definition
value="The average mass of a molecule of a compound compared to ¹/₁₂ the mass of carbon 12 and calculated as the sum of the atomic weights of the constituent atoms. [Source: Merriam Webster]"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.molecularWeight"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="SubstanceDefinition.molecularWeight.id">
<path value="SubstanceDefinition.molecularWeight.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.molecularWeight.extension">
<path value="SubstanceDefinition.molecularWeight.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.molecularWeight.modifierExtension">
<path value="SubstanceDefinition.molecularWeight.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="SubstanceDefinition.molecularWeight.method">
<path value="SubstanceDefinition.molecularWeight.method"/>
<short value="The method by which the weight was determined"/>
<definition
value="The method by which the molecular weight was determined."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.molecularWeight.method"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceWeightMethod"/>
</extension>
<strength value="example"/>
<description
value="The method by which the substance weight was measured."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/substance-weight-method"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="Molecular_Weight.Molecular_Weight_Method"/>
</mapping>
</element>
<element id="SubstanceDefinition.molecularWeight.type">
<path value="SubstanceDefinition.molecularWeight.type"/>
<short
value="Type of molecular weight e.g. exact, average, weight average"/>
<definition
value="Type of molecular weight such as exact, average (also known as. number average), weight average."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.molecularWeight.type"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceWeightType"/>
</extension>
<strength value="example"/>
<description value="The type of substance weight measurement."/>
<valueSet value="http://hl7.org/fhir/ValueSet/substance-weight-type"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="Molecular_Weight.Molecular_Weight_Type"/>
</mapping>
</element>
<element id="SubstanceDefinition.molecularWeight.amount">
<path value="SubstanceDefinition.molecularWeight.amount"/>
<short
value="Used to capture quantitative values for a variety of elements"/>
<definition
value="Used to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.molecularWeight.amount"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Quantity"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="extensible"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="Molecular_Weight.Amount"/>
</mapping>
</element>
<element id="SubstanceDefinition.molecularWeight.amount.id">
<path value="SubstanceDefinition.molecularWeight.amount.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="id"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.molecularWeight.amount.extension">
<path value="SubstanceDefinition.molecularWeight.amount.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.molecularWeight.amount.value">
<path value="SubstanceDefinition.molecularWeight.amount.value"/>
<short value="Numerical value (with implicit precision)"/>
<definition
value="The value of the measured amount. The value includes an implicit precision in the presentation of the value."/>
<comment
value="The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books)."/>
<requirements
value="Precision is handled implicitly in almost all cases of measurement."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Quantity.value"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="decimal"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="SN.2 / CQ - N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"/>
</mapping>
</element>
<element id="SubstanceDefinition.molecularWeight.amount.comparator">
<path value="SubstanceDefinition.molecularWeight.amount.comparator"/>
<short
value="< | <= | >= | > | ad - how to understand the value"/>
<definition
value="How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value."/>
<requirements
value="Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Quantity.comparator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<meaningWhenMissing
value="If there is no comparator, then there is no modification of the value"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="QuantityComparator"/>
</extension>
<strength value="required"/>
<description
value="How the Quantity should be understood and represented."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="SN.1 / CQ.1"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="IVL properties"/>
</mapping>
</element>
<element id="SubstanceDefinition.molecularWeight.amount.unit">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="SubstanceDefinition.molecularWeight.amount.unit"/>
<short value="Molecular Weight UOM"/>
<definition
value="The labeled unit of measure for the molecular weight. [Source: Adapted for NCI EVS C117055]"/>
<requirements
value="There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Quantity.unit"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="(see OBX.6 etc.) / CQ.2"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="PQ.unit"/>
</mapping>
</element>
<element id="SubstanceDefinition.molecularWeight.amount.system">
<path value="SubstanceDefinition.molecularWeight.amount.system"/>
<short value="System that defines coded unit form"/>
<definition
value="The identification of the system that provides the coded form of the unit."/>
<requirements
value="Need to know the system that defines the coded form of the unit."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Quantity.system"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<condition value="qty-3"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="(see OBX.6 etc.) / CQ.2"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CO.codeSystem, PQ.translation.codeSystem"/>
</mapping>
</element>
<element id="SubstanceDefinition.molecularWeight.amount.code">
<path value="SubstanceDefinition.molecularWeight.amount.code"/>
<short value="Coded form of the unit"/>
<definition
value="A computer processable form of the unit in some unit representation system."/>
<comment
value="The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system."/>
<requirements
value="Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Quantity.code"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<condition value="qty-3"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="(see OBX.6 etc.) / CQ.2"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="PQ.code, MO.currency, PQ.translation.code"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure">
<path value="SubstanceDefinition.structure"/>
<short value="Structural information"/>
<definition value="Structural information."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="cmc-structure-representation-required"/>
<severity value="error"/>
<human
value="Either a file or string structure representation is required"/>
<expression
value="representation.type.coding.where(
system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy'
and (code in ('C45253' | 'C103240'))
).exists()"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Substance.Structure"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.id">
<path value="SubstanceDefinition.structure.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.extension">
<path value="SubstanceDefinition.structure.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.modifierExtension">
<path value="SubstanceDefinition.structure.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.stereochemistry">
<path value="SubstanceDefinition.structure.stereochemistry"/>
<short value="Stereochemistry type"/>
<definition value="Stereochemistry type."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.stereochemistry"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceStereochemistry"/>
</extension>
<strength value="example"/>
<description value="The optical rotation type of a substance."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/substance-stereochemistry"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="Structure.Stereochemistry"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.opticalActivity">
<path value="SubstanceDefinition.structure.opticalActivity"/>
<short value="Optical activity type"/>
<definition value="Optical activity type."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.opticalActivity"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceOpticalActivity"/>
</extension>
<strength value="example"/>
<description value="The optical rotation type of a substance."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/substance-optical-activity"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="Structure.Optical_Activity"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.molecularFormula">
<path value="SubstanceDefinition.structure.molecularFormula"/>
<short value="Molecular Formula | Biopolymer Sequence"/>
<definition
value="Molecular Formula: An expression which states the number and type of atoms present in a molecule of a substance or sequence for biotechnology products. [Source: SME Defined]
Biopolymer Sequence: TBD"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.molecularFormula"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Structure.Molecular_Formula"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.molecularFormulaByMoiety">
<path value="SubstanceDefinition.structure.molecularFormulaByMoiety"/>
<short value="Specified per moiety according to the Hill system"/>
<definition
value="Specified per moiety according to the Hill system, i.e. first C, then H, then alphabetical, each moiety separated by a dot."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.molecularFormulaByMoiety"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Structure.Molecular_Formula_By_Moiety"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.molecularWeight">
<path value="SubstanceDefinition.structure.molecularWeight"/>
<short value="The molecular weight or weight range"/>
<definition
value="The molecular weight or weight range (for proteins, polymers or nucleic acids)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.molecularWeight"/>
<min value="0"/>
<max value="1"/>
</base>
<contentReference
value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.molecularWeight"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Structure.Molecular_Weight"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.technique">
<path value="SubstanceDefinition.structure.technique"/>
<short value="Substance Characterisation Technique"/>
<definition
value="The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay."/>
<comment
value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.technique"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceStructureTechnique"/>
</extension>
<strength value="example"/>
<description
value="The method used to elucidate the structure of the drug substance."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/substance-structure-technique"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a,CD"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.sourceDocument">
<path value="SubstanceDefinition.structure.sourceDocument"/>
<short value="Source of information for the structure"/>
<definition value="The source of information about the structure."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="SubstanceDefinition.structure.sourceDocument"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Structure.Reference_Source"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.representation">
<path value="SubstanceDefinition.structure.representation"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="type"/>
</discriminator>
<ordered value="false"/>
<rules value="closed"/>
</slicing>
<short
value="Impurity Structure Graphic | Impurity Structure Data File"/>
<definition value="A depiction of the structure of the substance."/>
<min value="1"/>
<max value="*"/>
<base>
<path value="SubstanceDefinition.structure.representation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Structure.Structural_Representation"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.representation.id">
<path value="SubstanceDefinition.structure.representation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.representation.extension">
<path value="SubstanceDefinition.structure.representation.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation.modifierExtension">
<path
value="SubstanceDefinition.structure.representation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.representation.type">
<path value="SubstanceDefinition.structure.representation.type"/>
<short
value="The kind of structural representation (e.g. full, partial)"/>
<definition
value="The kind of structural representation (e.g. full, partial)."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.representation.type"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map
value="Structural_Representation.Structural_Representation_Type"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation.representation">
<path
value="SubstanceDefinition.structure.representation.representation"/>
<short
value="The structural representation as a text string in a standard format"/>
<definition
value="The structural representation as a text string in a standard format."/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="SubstanceDefinition.structure.representation.representation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Structural_Representation.Structural_Representation"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.representation.format">
<path value="SubstanceDefinition.structure.representation.format"/>
<short
value="The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)"/>
<definition
value="The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.representation.format"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceRepresentationFormat"/>
</extension>
<strength value="example"/>
<description value="A format of a substance representation."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/substance-representation-format"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="n/a"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.representation.document">
<path value="SubstanceDefinition.structure.representation.document"/>
<short
value="An attachment with the structural representation e.g. a structure graphic or AnIML file"/>
<definition
value="An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.representation.document"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map
value="Structural_Representation.Structural_Representation_Attachment"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.representation:graphic">
<path value="SubstanceDefinition.structure.representation"/>
<sliceName value="graphic"/>
<short
value="A graphical, displayable depiction of the structure (e.g. an SVG, PNG)"/>
<definition value="A depiction of the structure of the substance."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.representation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Structure.Structural_Representation"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.representation:graphic.id">
<path value="SubstanceDefinition.structure.representation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:graphic.extension">
<path value="SubstanceDefinition.structure.representation.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:graphic.modifierExtension">
<path
value="SubstanceDefinition.structure.representation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.representation:graphic.type">
<path value="SubstanceDefinition.structure.representation.type"/>
<short value="Graphic"/>
<definition
value="The kind of structural representation (e.g. full, partial)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.representation.type"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<patternCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C54273"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceRepresentationType"/>
</extension>
<strength value="example"/>
<description value="A format of a substance representation."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/substance-representation-type"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map
value="Structural_Representation.Structural_Representation_Type"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:graphic.representation">
<path
value="SubstanceDefinition.structure.representation.representation"/>
<short
value="The structural representation as a text string in a standard format"/>
<definition
value="The structural representation as a text string in a standard format."/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="SubstanceDefinition.structure.representation.representation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Structural_Representation.Structural_Representation"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:graphic.format">
<path value="SubstanceDefinition.structure.representation.format"/>
<short
value="The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)"/>
<definition
value="The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.representation.format"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceRepresentationFormat"/>
</extension>
<strength value="example"/>
<description value="A format of a substance representation."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/substance-representation-format"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:graphic.document">
<path value="SubstanceDefinition.structure.representation.document"/>
<short value="Impurity Structure Graphic"/>
<definition
value="A pictorial representation of the structure of the impurity substance.
[Source: SME Defined] Note: Refer to the 'Acceptable File Formats for
use in eCTD' Example: This is the representation of the molecule CH3OH,
or the sequence SHLVEALALVAGERG."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.representation.document"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
<targetProfile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference"/>
<aggregation value="bundled"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map
value="Structural_Representation.Structural_Representation_Attachment"/>
</mapping>
</element>
<element id="SubstanceDefinition.structure.representation:structureFile">
<path value="SubstanceDefinition.structure.representation"/>
<sliceName value="structureFile"/>
<short value="machine-readable representation -- attached file"/>
<definition value="A depiction of the structure of the substance."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="SubstanceDefinition.structure.representation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Structure.Structural_Representation"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:structureFile.id">
<path value="SubstanceDefinition.structure.representation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:structureFile.extension">
<path value="SubstanceDefinition.structure.representation.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:structureFile.modifierExtension">
<path
value="SubstanceDefinition.structure.representation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:structureFile.type">
<path value="SubstanceDefinition.structure.representation.type"/>
<short value="Structure File"/>
<definition
value="The kind of structural representation (e.g. full, partial)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.representation.type"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<patternCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C103240"/>
</coding>
</patternCodeableConcept>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceRepresentationType"/>
</extension>
<strength value="example"/>
<description value="A format of a substance representation."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/substance-representation-type"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map
value="Structural_Representation.Structural_Representation_Type"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:structureFile.representation">
<path
value="SubstanceDefinition.structure.representation.representation"/>
<short
value="The structural representation as a text string in a standard format"/>
<definition
value="The structural representation as a text string in a standard format."/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="SubstanceDefinition.structure.representation.representation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Structural_Representation.Structural_Representation"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:structureFile.format">
<path value="SubstanceDefinition.structure.representation.format"/>
<short
value="The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)"/>
<definition
value="The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.representation.format"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SubstanceRepresentationFormat"/>
</extension>
<strength value="example"/>
<description value="A format of a substance representation."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/substance-representation-format"/>
</binding>
<mapping>
<identity value="idmp-substance"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:structureFile.document">
<path value="SubstanceDefinition.structure.representation.document"/>
<short
value="Impurity Chemical Structure Data (files, e.g. .SDF, .CIF)"/>
<definition
value="An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="SubstanceDefinition.structure.representation.document"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
<targetProfile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-structure-reference"/>
<aggregation value="bundled"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map
value="Structural_Representation.Structural_Representation_Attachment"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:structureString">
<path value="SubstanceDefinition.structure.representation"/>
<sliceName value="structureString"/>
<short value="machine-readable representation -- plain text"/>
<definition value="A depiction of the structure of the substance."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="SubstanceDefinition.structure.representation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp-substance"/>
<map value="Structure.Structural_Representation"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:structureString.id">
<path value="SubstanceDefinition.structure.representation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:structureString.extension">
<path value="SubstanceDefinition.structure.representation.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:structureString.modifierExtension">
<path
value="SubstanceDefinition.structure.representation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="SubstanceDefinition.structure.representation:structureString.type">
<path