Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
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 2.0.0-ballot 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 2024-12-04 |
XML representation of the pqcmc-component resource profile.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="pqcmc-component"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: StructureDefinition pqcmc-component</b></p><a name="pqcmc-component"> </a><a name="hcpqcmc-component"> </a><a name="pqcmc-component-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,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" 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-component-definitions.html#Ingredient">Ingredient</a><a name="Ingredient"> </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"><a href="http://hl7.org/fhir/R5/ingredient.html">Ingredient</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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-component-definitions.html#Ingredient.for">for</a><a name="Ingredient.for"> </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">*</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="http://hl7.org/fhir/R5/references.html">Reference</a>(<a style="opacity: 0.5" href="http://hl7.org/fhir/R5/medicinalproductdefinition.html">MedicinalProductDefinition</a> | <a style="opacity: 0.5" href="http://hl7.org/fhir/R5/administrableproductdefinition.html">AdministrableProductDefinition</a> | <a style="opacity: 0.5" href="http://hl7.org/fhir/R5/manufactureditemdefinition.html">ManufacturedItemDefinition</a>)</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Reference to MedicinalProductDefinition</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-component-definitions.html#Ingredient.role">role</a><a name="Ingredient.role"> </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#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">Purpose of the ingredient within the product, e.g. active, inactive</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-drug-product-component-function-category-terminology.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology">Drug Product Component Function Category 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: #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-component-definitions.html#Ingredient.comment" title="A placeholder for providing any comments that are relevant to the component. [Source: SME Defined]
Examples: removed during process, adjusted for loss on drying, etc.">comment</a><a name="Ingredient.comment"> </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">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#markdown">markdown</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 Product Component Additional Information</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_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: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-definitions.html#Ingredient.substance">substance</a><a name="Ingredient.substance"> </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-strength-type-cases2 )">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">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/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">The substance that comprises this ingredient</span><br/><span style="font-weight:bold">cmc-strength-type-cases2: </span>IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements.
Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity.</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_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: #F7F7F7; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-definitions.html#Ingredient.substance.code">code</a><a name="Ingredient.substance.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"><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">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-literal-codeable-reference.html" title="Literal Coded Reference">LiteralCodeableReference</a>(<a href="StructureDefinition-pqcmc-component-substance.html">Component Substance</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">Ingredient Substance</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_bck003.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_slice.png" alt="." style="background-color: white; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-pqcmc-component-definitions.html#Ingredient.substance.strength">Slices for strength</a><a name="Ingredient.substance.strength"> </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">2</span><span style="font-style: italic">..</span><span style="font-style: italic">2</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">The quantity of substance, per presentation, or per volume or mass, and type of quantity</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Closed by exists:textConcentration</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_bck0035.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_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-component-definitions.html#Ingredient.substance.strength:amount" title="Slice amount">strength:amount</a><a name="Ingredient.substance.strength.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/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">The quantity of substance, per presentation, or per volume or mass, and type of quantity</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_bck00353.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_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_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-definitions.html#Ingredient.substance.strength:amount.extension">Slices for extension</a><a name="Ingredient.substance.strength.extension"> </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">*</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/extensibility.html#Extension">Extension</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">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url</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_bck003524.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_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_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-component-definitions.html#Ingredient.substance.strength:amount.extension:strengthFactors" title="Extension URL = http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension">strengthFactors</a><a name="Ingredient.substance.strength.extension.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 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">Strength Extension</span><br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-strength-extension.html">http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension</a><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-strength-type-terminology.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology">Strength 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_bck00353.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_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_slice.png" alt="." style="background-color: white; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-pqcmc-component-definitions.html#Ingredient.substance.strength:amount.concentration[x]">Slices for concentration[x]</a><a name="Ingredient.substance.strength.concentration_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"><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">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"/><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">The strength per unitary volume (or mass)</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Open by type:$this</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_bck003530.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_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_slicer.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"/> <span title="Ratio Type: A relationship of two Quantity values - expressed as a numerator and a denominator.">concentrationRatio</span></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><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#Ratio">Ratio</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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_bck003530.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_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_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <span title="Quantity Type: A measured amount (or an amount that can potentially be measured). Note that measured amounts include amounts that are not precisely quantified, including amounts involving arbitrary units and floating currencies.">concentrationQuantity</span></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><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#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"/></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_bck003535.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_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_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-component-definitions.html#Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity" title="Slice concentrationQuantity">concentration[x]:concentrationQuantity</a><a name="Ingredient.substance.strength.concentration_x_.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">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 href="http://hl7.org/fhir/R5/datatypes.html#Quantity">Quantity</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 strength per unitary volume (or mass)</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-non-percentage-units.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units">Non-Percentage Units</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_bck0035350.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_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_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-component-definitions.html#Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.value" title="Specifies the quantity of an ingredient in a single dose unit (e.g., one tablet, capsule) of the drug product. [Source: SME Defined]
Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Ingredient Total Amount Numeric = 325">value</a><a name="Ingredient.substance.strength.concentration_x_.value"> </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#decimal">decimal</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Ingredient Total Amount Numeric</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_bck0035350.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_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_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-component-definitions.html#Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator" title="A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT.
Note: This is typically applicable to biologics.">comparator</a><a name="Ingredient.substance.strength.concentration_x_.comparator"> </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">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#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">Ingredient Total Amount Operator</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_bck0035340.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_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_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-component-definitions.html#Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.unit">unit</a><a name="Ingredient.substance.strength.concentration_x_.unit"> </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 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">Unit representation</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_bck003525.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_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_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-component-definitions.html#Ingredient.substance.strength:amount.concentration[x]:concentrationRatio" title="Slice concentrationRatio">concentration[x]:concentrationRatio</a><a name="Ingredient.substance.strength.concentration_x_.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 href="http://hl7.org/fhir/R5/datatypes.html#Ratio">Ratio</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 strength per unitary volume (or mass)</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_bck0035251.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_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_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-component-definitions.html#Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator" title="Specifies the quantity of an ingredient in a single dose unit of the drug product. [Source: SME Defined]">numerator</a><a name="Ingredient.substance.strength.concentration_x_.numerator"> </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#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">Numerator value</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-non-percentage-units.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units">Non-Percentage Units</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_bck00352510.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_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_vline_slice.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-component-definitions.html#Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.value">value</a><a name="Ingredient.substance.strength.concentration_x_.numerator.value"> </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#decimal">decimal</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Ingredient Total Amount Numeric Numerator</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_bck00352510.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_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_vline_slice.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-component-definitions.html#Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.unit" title="The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI EVS C117055]
Example: mg">unit</a><a name="Ingredient.substance.strength.concentration_x_.numerator.unit"> </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#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">Ingredient Total Amount Numeric Numerator UOM</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_bck00352500.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_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_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_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-definitions.html#Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.code">code</a><a name="Ingredient.substance.strength.concentration_x_.numerator.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"><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#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"><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: 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_bck0035241.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_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_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-component-definitions.html#Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator">denominator</a><a name="Ingredient.substance.strength.concentration_x_.denominator"> </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#SimpleQuantity" title="Quantity">SimpleQuantity</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">Denominator value</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-non-percentage-units.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units">Non-Percentage Units</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_bck00352410.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_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_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-component-definitions.html#Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.value" title="Specifies the quantity of the ingredients within a single dose unit (e.g., vial, syringe) of drug product. [Source: SME Defined]
Example: 10mg/syringe, 1mg/ml">value</a><a name="Ingredient.substance.strength.concentration_x_.denominator.value"> </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#decimal">decimal</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Ingredient Total Amount Numeric Denominator</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_bck00352410.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_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_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: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-definitions.html#Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.unit">unit</a><a name="Ingredient.substance.strength.concentration_x_.denominator.unit"> </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">Ingredient Total Amount Numeric Denominator UOM</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_bck00352400.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_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_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-component-definitions.html#Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.code">code</a><a name="Ingredient.substance.strength.concentration_x_.denominator.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"><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#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"><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: 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_bck00340.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_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-component-definitions.html#Ingredient.substance.strength:amount.textConcentration" title="A written description of the strength of the ingredient. [Source: SME Defined]">textConcentration</a><a name="Ingredient.substance.strength.textConcentration"> </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">Strength Textual</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_bck0025.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_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-component-definitions.html#Ingredient.substance.strength:percent" title="Slice percent">strength:percent</a><a name="Ingredient.substance.strength.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..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">The quantity of substance, per presentation, or per volume or mass, and type of quantity</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_bck00251.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_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_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-definitions.html#Ingredient.substance.strength:percent.concentration[x]">concentration[x]</a><a name="Ingredient.substance.strength.concentration_x_.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">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="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">The strength per unitary volume (or mass)</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-percentage-units.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units">Percentage Units</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_bck002510.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_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.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-component-definitions.html#Ingredient.substance.strength:percent.concentration[x].value" title="The percentage of the component in the drug product. [Source: SME Defined]
Example: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08">value</a><a name="Ingredient.substance.strength.concentration_x_.value.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#decimal">decimal</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Ingredient Total Amount Content Percent</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_bck002500.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_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_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-definitions.html#Ingredient.substance.strength:percent.concentration[x].code">code</a><a name="Ingredient.substance.strength.concentration_x_.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">Ingredient Total Amount Content Percent UOM</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_bck00240.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_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"/> <span style="text-decoration:line-through">textConcentration</span><a name="Ingredient.substance.strength.textConcentration.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="text-decoration:line-through" 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="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></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"/></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-component"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.36.42.23"/>
</identifier>
<version value="2.0.0-ballot"/>
<name value="DrugProductComponent"/>
<title value="Drug Product Component"/>
<status value="active"/>
<date value="2024-12-04T20:50:29+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="The amount details about the drug product components to define the product composition in a product unit. Use composition."/>
<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"/>
<uri value="https://www.iso.org/obp/ui/#iso:std:iso:11615"/>
<name value="IDMP Mapping"/>
</mapping>
<mapping>
<identity value="rim"/>
<uri value="http://hl7.org/v3"/>
<name value="RIM Mapping"/>
</mapping>
<kind value="resource"/>
<abstract value="false"/>
<type value="Ingredient"/>
<baseDefinition value="http://hl7.org/fhir/StructureDefinition/Ingredient"/>
<derivation value="constraint"/>
<snapshot>
<element id="Ingredient">
<path value="Ingredient"/>
<short
value="An ingredient of a manufactured item or pharmaceutical product"/>
<definition
value="An ingredient of a manufactured item or pharmaceutical product."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Ingredient"/>
<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="ing-1"/>
<severity value="error"/>
<human
value="If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource"/>
<expression
value="Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2"/>
<source value="http://hl7.org/fhir/StructureDefinition/Ingredient"/>
</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"/>
<map value="Ingredient"/>
</mapping>
</element>
<element id="Ingredient.id">
<path value="Ingredient.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="Ingredient.meta">
<path value="Ingredient.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="Ingredient.implicitRules">
<path value="Ingredient.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="Ingredient.language">
<path value="Ingredient.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="Ingredient.text">
<path value="Ingredient.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="Ingredient.contained">
<path value="Ingredient.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="Ingredient.extension">
<path value="Ingredient.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="Ingredient.modifierExtension">
<path value="Ingredient.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="Ingredient.identifier">
<path value="Ingredient.identifier"/>
<short
value="An identifier or code by which the ingredient can be referenced"/>
<definition
value="The identifier(s) of this Ingredient that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.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="w5"/>
<map value="FiveWs.class"/>
</mapping>
<mapping>
<identity value="idmp"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.status">
<path value="Ingredient.status"/>
<short value="draft | active | retired | unknown"/>
<definition
value="The status of this ingredient. Enables tracking the life-cycle of the content."/>
<comment
value="Allows filtering of ingredient that are appropriate for use versus not."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Ingredient.status"/>
<min value="1"/>
<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="true"/>
<isModifierReason
value="This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="PublicationStatus"/>
</extension>
<strength value="required"/>
<description value="The lifecycle status of an artifact."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/publication-status|5.0.0"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.for">
<path value="Ingredient.for"/>
<short value="Reference to MedicinalProductDefinition"/>
<definition
value="The product which this ingredient is a constituent part of."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Ingredient.for"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/AdministrableProductDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition"/>
</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"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.role">
<path value="Ingredient.role"/>
<short
value="Purpose of the ingredient within the product, e.g. active, inactive"/>
<definition
value="A classification of the ingredient identifying its purpose within the product, e.g. active, inactive."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Ingredient.role"/>
<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>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Ingredient.Ingredient Role"/>
</mapping>
</element>
<element id="Ingredient.function">
<path value="Ingredient.function"/>
<short
value="Precise action within the drug product, e.g. antioxidant, alkalizing agent"/>
<definition
value="A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Ingredient.function"/>
<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="IngredientFunction"/>
</extension>
<strength value="example"/>
<description
value="A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive)."/>
<valueSet value="http://hl7.org/fhir/ValueSet/ingredient-function"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.group">
<path value="Ingredient.group"/>
<short
value="A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink"/>
<definition
value="A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.group"/>
<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"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.allergenicIndicator">
<path value="Ingredient.allergenicIndicator"/>
<short value="If the ingredient is a known or suspected allergen"/>
<definition
value="If the ingredient is a known or suspected allergen. Note that this is a property of the substance, so if a reference to a SubstanceDefinition is used to decribe that (rather than just a code), the allergen information should go there, not here."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.allergenicIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="boolean"/>
</type>
<meaningWhenMissing
value="If this value is not present, there is no statement being made about whether this is an allergen or not. No inference can be made"/>
<condition value="ing-1"/>
<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"/>
<map value="Ingredient.Allergenic Indicator"/>
</mapping>
</element>
<element id="Ingredient.comment">
<path value="Ingredient.comment"/>
<short value="Drug Product Component Additional Information"/>
<definition
value="A placeholder for providing any comments that are relevant to the component. [Source: SME Defined]
Examples: removed during process, adjusted for loss on drying, etc."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.comment"/>
<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="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="idmp"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.manufacturer">
<path value="Ingredient.manufacturer"/>
<short value="An organization that manufactures this ingredient"/>
<definition
value="The organization(s) that manufacture this ingredient. Can be used to indicate: 1) Organizations we are aware of that manufacture this ingredient 2) Specific Manufacturer(s) currently being used 3) Set of organisations allowed to manufacture this ingredient for this product Users must be clear on the application of context relevant to their use case."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Ingredient.manufacturer"/>
<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"/>
<map value="Ingredient.manufacturer"/>
</mapping>
</element>
<element id="Ingredient.manufacturer.id">
<path value="Ingredient.manufacturer.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="Ingredient.manufacturer.extension">
<path value="Ingredient.manufacturer.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="Ingredient.manufacturer.modifierExtension">
<path value="Ingredient.manufacturer.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="Ingredient.manufacturer.role">
<path value="Ingredient.manufacturer.role"/>
<short value="allowed | possible | actual"/>
<definition
value="The way in which this manufacturer is associated with the ingredient. For example whether it is a possible one (others allowed), or an exclusive authorized one for this ingredient. Note that this is not the manufacturing process role."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.manufacturer.role"/>
<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="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IngredientManufacturerRole"/>
</extension>
<strength value="required"/>
<description
value="The way in which this manufacturer is associated with the ingredient."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Ingredient.Manufacturer / Establishment (Organisation)"/>
</mapping>
</element>
<element id="Ingredient.manufacturer.manufacturer">
<path value="Ingredient.manufacturer.manufacturer"/>
<short value="An organization that manufactures this ingredient"/>
<definition value="An organization that manufactures this ingredient."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Ingredient.manufacturer.manufacturer"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</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"/>
<map value="Ingredient.Manufacturer / Establishment (Organisation)"/>
</mapping>
</element>
<element id="Ingredient.substance">
<path value="Ingredient.substance"/>
<short value="The substance that comprises this ingredient"/>
<definition value="The substance that comprises this ingredient."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Ingredient.substance"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<condition value="ing-1"/>
<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-strength-type-cases2"/>
<severity value="error"/>
<human
value="IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements.
Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity."/>
<expression
value="defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(
strength
.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension')
.extension.where(
value.coding.where(
code = 'C45420' and
system = %system
).exists()
).exists()
implies (
strength.presentation.ofType(Ratio).exists() and
strength.presentation.numerator.where(
code = '[arb\'U]' and
system = 'http://unitsofmeasure.org'
)
) or (
strength.presentation.ofType(Quantity).exists() and
strength.presentation.where(
code = '[arb\'U]' and
system = 'http://unitsofmeasure.org'
)
))"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Ingredient.Substance"/>
</mapping>
</element>
<element id="Ingredient.substance.id">
<path value="Ingredient.substance.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="Ingredient.substance.extension">
<path value="Ingredient.substance.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="Ingredient.substance.modifierExtension">
<path value="Ingredient.substance.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="Ingredient.substance.code">
<path value="Ingredient.substance.code"/>
<short value="Ingredient Substance"/>
<definition
value="A reference to a resource (by instance), or instead, a reference to a concept defined in a terminology or ontology (by class)."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.code"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="CodeableReference"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference"/>
<targetProfile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"/>
<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"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="SNOMEDCTSubstanceCodes"/>
</extension>
<strength value="example"/>
<description
value="This value set includes all substance codes from SNOMED CT - provided as an exemplar value set."/>
<valueSet value="http://hl7.org/fhir/ValueSet/substance-codes"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.substance.strength">
<path value="Ingredient.substance.strength"/>
<slicing>
<discriminator>
<type value="exists"/>
<path value="textConcentration"/>
</discriminator>
<ordered value="false"/>
<rules value="closed"/>
</slicing>
<short
value="The quantity of substance, per presentation, or per volume or mass, and type of quantity"/>
<definition
value="The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength."/>
<min value="2"/>
<max value="2"/>
<base>
<path value="Ingredient.substance.strength"/>
<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"/>
<map value="Specified Substance.Strength"/>
</mapping>
</element>
<element id="Ingredient.substance.strength.id">
<path value="Ingredient.substance.strength.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="Ingredient.substance.strength.extension">
<path value="Ingredient.substance.strength.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="Ingredient.substance.strength.modifierExtension">
<path value="Ingredient.substance.strength.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="Ingredient.substance.strength.presentation[x]">
<path value="Ingredient.substance.strength.presentation[x]"/>
<short value="The quantity of substance in the unit of presentation"/>
<definition
value="The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg')."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.presentation[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Ratio"/>
</type>
<type>
<code value="RatioRange"/>
</type>
<type>
<code value="CodeableConcept"/>
</type>
<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="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Strength.Strength (Presentation)"/>
</mapping>
</element>
<element id="Ingredient.substance.strength.textPresentation">
<path value="Ingredient.substance.strength.textPresentation"/>
<short
value="Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)"/>
<definition
value="A textual represention of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.textPresentation"/>
<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"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.substance.strength.concentration[x]">
<path value="Ingredient.substance.strength.concentration[x]"/>
<short value="The strength per unitary volume (or mass)"/>
<definition value="The strength per unitary volume (or mass)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.concentration[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Ratio"/>
</type>
<type>
<code value="RatioRange"/>
</type>
<type>
<code value="CodeableConcept"/>
</type>
<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="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Strength.Strength (Concentration)"/>
</mapping>
</element>
<element id="Ingredient.substance.strength.textConcentration">
<path value="Ingredient.substance.strength.textConcentration"/>
<short
value="Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)"/>
<definition
value="A textual represention of either the whole of the concentration strength or a part of it - with the rest being in Strength.concentration as a ratio."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.textConcentration"/>
<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"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.substance.strength.basis">
<path value="Ingredient.substance.strength.basis"/>
<short
value="A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)"/>
<definition
value="A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.basis"/>
<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"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.substance.strength.measurementPoint">
<path value="Ingredient.substance.strength.measurementPoint"/>
<short
value="When strength is measured at a particular point or distance"/>
<definition
value="For when strength is measured at a particular point or distance. There are products where strength is measured at a particular point. For example, the strength of the ingredient in some inhalers is measured at a particular position relative to the point of aerosolization."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.measurementPoint"/>
<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"/>
<map value="Strength.Measurement Point"/>
</mapping>
</element>
<element id="Ingredient.substance.strength.country">
<path value="Ingredient.substance.strength.country"/>
<short value="Where the strength range applies"/>
<definition
value="The country or countries for which the strength range applies."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Ingredient.substance.strength.country"/>
<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="Country"/>
</extension>
<strength value="example"/>
<description value="Jurisdiction codes"/>
<valueSet value="http://hl7.org/fhir/ValueSet/country"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Strength.Country"/>
</mapping>
</element>
<element id="Ingredient.substance.strength.referenceStrength">
<path value="Ingredient.substance.strength.referenceStrength"/>
<short value="Strength expressed in terms of a reference substance"/>
<definition
value="Strength expressed in terms of a reference substance. For when the ingredient strength is additionally expressed as equivalent to the strength of some other closely related substance (e.g. salt vs. base). Reference strength represents the strength (quantitative composition) of the active moiety of the active substance. There are situations when the active substance and active moiety are different, therefore both a strength and a reference strength are needed."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Ingredient.substance.strength.referenceStrength"/>
<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"/>
<map value="Strength.Reference Strength"/>
</mapping>
</element>
<element id="Ingredient.substance.strength.referenceStrength.id">
<path value="Ingredient.substance.strength.referenceStrength.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="Ingredient.substance.strength.referenceStrength.extension">
<path
value="Ingredient.substance.strength.referenceStrength.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="Ingredient.substance.strength.referenceStrength.modifierExtension">
<path
value="Ingredient.substance.strength.referenceStrength.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="Ingredient.substance.strength.referenceStrength.substance">
<path
value="Ingredient.substance.strength.referenceStrength.substance"/>
<short value="Relevant reference substance"/>
<definition value="Relevant reference substance."/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="Ingredient.substance.strength.referenceStrength.substance"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="CodeableReference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"/>
</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="SNOMEDCTSubstanceCodes"/>
</extension>
<strength value="example"/>
<description
value="This value set includes all substance codes from SNOMED CT - provided as an exemplar value set."/>
<valueSet value="http://hl7.org/fhir/ValueSet/substance-codes"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Reference Strength.Reference Substance"/>
</mapping>
</element>
<element
id="Ingredient.substance.strength.referenceStrength.strength[x]">
<path
value="Ingredient.substance.strength.referenceStrength.strength[x]"/>
<short value="Strength expressed in terms of a reference substance"/>
<definition
value="Strength expressed in terms of a reference substance."/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="Ingredient.substance.strength.referenceStrength.strength[x]"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Ratio"/>
</type>
<type>
<code value="RatioRange"/>
</type>
<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="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Reference Strength.Reference Strength"/>
</mapping>
</element>
<element
id="Ingredient.substance.strength.referenceStrength.measurementPoint">
<path
value="Ingredient.substance.strength.referenceStrength.measurementPoint"/>
<short
value="When strength is measured at a particular point or distance"/>
<definition
value="For when strength is measured at a particular point or distance."/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="Ingredient.substance.strength.referenceStrength.measurementPoint"/>
<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"/>
<map value="Reference Strength.Measurement Point"/>
</mapping>
</element>
<element id="Ingredient.substance.strength.referenceStrength.country">
<path value="Ingredient.substance.strength.referenceStrength.country"/>
<short value="Where the strength range applies"/>
<definition
value="The country or countries for which the strength range applies."/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="Ingredient.substance.strength.referenceStrength.country"/>
<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="Country"/>
</extension>
<strength value="example"/>
<description value="Jurisdiction codes"/>
<valueSet value="http://hl7.org/fhir/ValueSet/country"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Reference Strength.Country"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:amount">
<path value="Ingredient.substance.strength"/>
<sliceName value="amount"/>
<short
value="The quantity of substance, per presentation, or per volume or mass, and type of quantity"/>
<definition
value="The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength"/>
<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"/>
<map value="Specified Substance.Strength"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:amount.id">
<path value="Ingredient.substance.strength.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="Ingredient.substance.strength:amount.extension">
<path value="Ingredient.substance.strength.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<short value="Extension"/>
<definition value="An Extension"/>
<min value="1"/>
<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"/>
</element>
<element
id="Ingredient.substance.strength:amount.extension:strengthFactors">
<path value="Ingredient.substance.strength.extension"/>
<sliceName value="strengthFactors"/>
<short value="Strength Extension"/>
<definition value="Strength Type (for API)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-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="true"/>
<isModifier value="false"/>
</element>
<element id="Ingredient.substance.strength:amount.modifierExtension">
<path value="Ingredient.substance.strength.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="Ingredient.substance.strength:amount.presentation[x]">
<path value="Ingredient.substance.strength.presentation[x]"/>
<short value="The quantity of substance in the unit of presentation"/>
<definition
value="The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg')."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.presentation[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Ratio"/>
</type>
<type>
<code value="RatioRange"/>
</type>
<type>
<code value="CodeableConcept"/>
</type>
<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="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Strength.Strength (Presentation)"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:amount.textPresentation">
<path value="Ingredient.substance.strength.textPresentation"/>
<short
value="Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)"/>
<definition
value="A textual represention of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.textPresentation"/>
<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"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:amount.concentration[x]">
<path value="Ingredient.substance.strength.concentration[x]"/>
<slicing>
<discriminator>
<type value="type"/>
<path value="$this"/>
</discriminator>
<ordered value="false"/>
<rules value="closed"/>
</slicing>
<short value="The strength per unitary volume (or mass)"/>
<definition value="The strength per unitary volume (or mass)."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.concentration[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Ratio"/>
</type>
<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"/>
<mapping>
<identity value="idmp"/>
<map value="Strength.Strength (Concentration)"/>
</mapping>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity">
<path value="Ingredient.substance.strength.concentration[x]"/>
<sliceName value="concentrationQuantity"/>
<short value="The strength per unitary volume (or mass)"/>
<definition value="The strength per unitary volume (or mass)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.concentration[x]"/>
<min value="0"/>
<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="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Strength.Strength (Concentration)"/>
</mapping>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.id">
<path value="Ingredient.substance.strength.concentration[x].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="Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.extension">
<path value="Ingredient.substance.strength.concentration[x].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="Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.value">
<path value="Ingredient.substance.strength.concentration[x].value"/>
<short value="Ingredient Total Amount Numeric"/>
<definition
value="Specifies the quantity of an ingredient in a single dose unit (e.g., one tablet, capsule) of the drug product. [Source: SME Defined]
Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Ingredient Total Amount Numeric = 325"/>
<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="1"/>
<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>
<mustSupport value="true"/>
<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="Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator">
<path
value="Ingredient.substance.strength.concentration[x].comparator"/>
<short value="Ingredient Total Amount Operator"/>
<definition
value="A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT.
Note: This is typically applicable to biologics."/>
<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>
<mustSupport value="true"/>
<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="Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.unit">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="Ingredient.substance.strength.concentration[x].unit"/>
<short value="Unit representation"/>
<definition value="A human-readable form of the unit."/>
<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="1"/>
<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="Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.system">
<path value="Ingredient.substance.strength.concentration[x].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="Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.code">
<path value="Ingredient.substance.strength.concentration[x].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="0"/>
<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>
<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="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio">
<path value="Ingredient.substance.strength.concentration[x]"/>
<sliceName value="concentrationRatio"/>
<short value="The strength per unitary volume (or mass)"/>
<definition value="The strength per unitary volume (or mass)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.concentration[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Ratio"/>
</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"/>
<map value="Strength.Strength (Concentration)"/>
</mapping>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.id">
<path value="Ingredient.substance.strength.concentration[x].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="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.extension">
<path value="Ingredient.substance.strength.concentration[x].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="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator">
<path value="Ingredient.substance.strength.concentration[x].numerator"/>
<short value="Numerator value"/>
<definition
value="Specifies the quantity of an ingredient in a single dose unit of the drug product. [Source: SME Defined]"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Ratio.numerator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Quantity"/>
</type>
<condition value="rat-1"/>
<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-non-percentage-units"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".numerator"/>
</mapping>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.id">
<path
value="Ingredient.substance.strength.concentration[x].numerator.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="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.extension">
<path
value="Ingredient.substance.strength.concentration[x].numerator.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="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.value">
<path
value="Ingredient.substance.strength.concentration[x].numerator.value"/>
<short value="Ingredient Total Amount Numeric Numerator"/>
<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="1"/>
<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>
<mustSupport value="true"/>
<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="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.comparator">
<path
value="Ingredient.substance.strength.concentration[x].numerator.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="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.unit">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path
value="Ingredient.substance.strength.concentration[x].numerator.unit"/>
<short value="Ingredient Total Amount Numeric Numerator UOM"/>
<definition
value="The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI EVS C117055]
Example: mg"/>
<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="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.system">
<path
value="Ingredient.substance.strength.concentration[x].numerator.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="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.code">
<path
value="Ingredient.substance.strength.concentration[x].numerator.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="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator">
<path
value="Ingredient.substance.strength.concentration[x].denominator"/>
<short value="Denominator value"/>
<definition value="The value of the denominator."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Ratio.denominator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Quantity"/>
<profile
value="http://hl7.org/fhir/StructureDefinition/SimpleQuantity"/>
</type>
<condition value="rat-1"/>
<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-non-percentage-units"/>
</binding>
<mapping>
<identity value="rim"/>
<map value=".denominator"/>
</mapping>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.id">
<path
value="Ingredient.substance.strength.concentration[x].denominator.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="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.extension">
<path
value="Ingredient.substance.strength.concentration[x].denominator.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="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.value">
<path
value="Ingredient.substance.strength.concentration[x].denominator.value"/>
<short value="Ingredient Total Amount Numeric Denominator"/>
<definition
value="Specifies the quantity of the ingredients within a single dose unit (e.g., vial, syringe) of drug product. [Source: SME Defined]
Example: 10mg/syringe, 1mg/ml"/>
<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="1"/>
<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>
<mustSupport value="true"/>
<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="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.comparator">
<path
value="Ingredient.substance.strength.concentration[x].denominator.comparator"/>
<short
value="< | <= | >= | > | ad - how to understand the value"/>
<definition value="Not allowed to be used in this context"/>
<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="0"/>
<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="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.unit">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path
value="Ingredient.substance.strength.concentration[x].denominator.unit"/>
<short value="Ingredient Total Amount Numeric Denominator UOM"/>
<definition value="A human-readable form of the unit."/>
<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="1"/>
<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>
<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.unit"/>
</mapping>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.system">
<path
value="Ingredient.substance.strength.concentration[x].denominator.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="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.code">
<path
value="Ingredient.substance.strength.concentration[x].denominator.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="Ingredient.substance.strength:amount.textConcentration">
<path value="Ingredient.substance.strength.textConcentration"/>
<short value="Strength Textual"/>
<definition
value="A written description of the strength of the ingredient. [Source: SME Defined]"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.textConcentration"/>
<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"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:amount.basis">
<path value="Ingredient.substance.strength.basis"/>
<short
value="A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)"/>
<definition
value="A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.basis"/>
<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"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:amount.measurementPoint">
<path value="Ingredient.substance.strength.measurementPoint"/>
<short
value="When strength is measured at a particular point or distance"/>
<definition
value="For when strength is measured at a particular point or distance. There are products where strength is measured at a particular point. For example, the strength of the ingredient in some inhalers is measured at a particular position relative to the point of aerosolization."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.measurementPoint"/>
<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"/>
<map value="Strength.Measurement Point"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:amount.country">
<path value="Ingredient.substance.strength.country"/>
<short value="Where the strength range applies"/>
<definition
value="The country or countries for which the strength range applies."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Ingredient.substance.strength.country"/>
<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="Country"/>
</extension>
<strength value="example"/>
<description value="Jurisdiction codes"/>
<valueSet value="http://hl7.org/fhir/ValueSet/country"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Strength.Country"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:amount.referenceStrength">
<path value="Ingredient.substance.strength.referenceStrength"/>
<short value="Strength expressed in terms of a reference substance"/>
<definition
value="Strength expressed in terms of a reference substance. For when the ingredient strength is additionally expressed as equivalent to the strength of some other closely related substance (e.g. salt vs. base). Reference strength represents the strength (quantitative composition) of the active moiety of the active substance. There are situations when the active substance and active moiety are different, therefore both a strength and a reference strength are needed."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Ingredient.substance.strength.referenceStrength"/>
<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"/>
<map value="Strength.Reference Strength"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:amount.referenceStrength.id">
<path value="Ingredient.substance.strength.referenceStrength.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="Ingredient.substance.strength:amount.referenceStrength.extension">
<path
value="Ingredient.substance.strength.referenceStrength.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="Ingredient.substance.strength:amount.referenceStrength.modifierExtension">
<path
value="Ingredient.substance.strength.referenceStrength.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="Ingredient.substance.strength:amount.referenceStrength.substance">
<path
value="Ingredient.substance.strength.referenceStrength.substance"/>
<short value="Relevant reference substance"/>
<definition value="Relevant reference substance."/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="Ingredient.substance.strength.referenceStrength.substance"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="CodeableReference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"/>
</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="SNOMEDCTSubstanceCodes"/>
</extension>
<strength value="example"/>
<description
value="This value set includes all substance codes from SNOMED CT - provided as an exemplar value set."/>
<valueSet value="http://hl7.org/fhir/ValueSet/substance-codes"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Reference Strength.Reference Substance"/>
</mapping>
</element>
<element
id="Ingredient.substance.strength:amount.referenceStrength.strength[x]">
<path
value="Ingredient.substance.strength.referenceStrength.strength[x]"/>
<short value="Strength expressed in terms of a reference substance"/>
<definition
value="Strength expressed in terms of a reference substance."/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="Ingredient.substance.strength.referenceStrength.strength[x]"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Ratio"/>
</type>
<type>
<code value="RatioRange"/>
</type>
<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="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Reference Strength.Reference Strength"/>
</mapping>
</element>
<element
id="Ingredient.substance.strength:amount.referenceStrength.measurementPoint">
<path
value="Ingredient.substance.strength.referenceStrength.measurementPoint"/>
<short
value="When strength is measured at a particular point or distance"/>
<definition
value="For when strength is measured at a particular point or distance."/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="Ingredient.substance.strength.referenceStrength.measurementPoint"/>
<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"/>
<map value="Reference Strength.Measurement Point"/>
</mapping>
</element>
<element
id="Ingredient.substance.strength:amount.referenceStrength.country">
<path value="Ingredient.substance.strength.referenceStrength.country"/>
<short value="Where the strength range applies"/>
<definition
value="The country or countries for which the strength range applies."/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="Ingredient.substance.strength.referenceStrength.country"/>
<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="Country"/>
</extension>
<strength value="example"/>
<description value="Jurisdiction codes"/>
<valueSet value="http://hl7.org/fhir/ValueSet/country"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Reference Strength.Country"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:percent">
<path value="Ingredient.substance.strength"/>
<sliceName value="percent"/>
<short
value="The quantity of substance, per presentation, or per volume or mass, and type of quantity"/>
<definition
value="The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength"/>
<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"/>
<map value="Specified Substance.Strength"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:percent.id">
<path value="Ingredient.substance.strength.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="Ingredient.substance.strength:percent.extension">
<path value="Ingredient.substance.strength.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="Ingredient.substance.strength:percent.modifierExtension">
<path value="Ingredient.substance.strength.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="Ingredient.substance.strength:percent.presentation[x]">
<path value="Ingredient.substance.strength.presentation[x]"/>
<short value="The quantity of substance in the unit of presentation"/>
<definition
value="The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg')."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.presentation[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Ratio"/>
</type>
<type>
<code value="RatioRange"/>
</type>
<type>
<code value="CodeableConcept"/>
</type>
<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="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Strength.Strength (Presentation)"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:percent.textPresentation">
<path value="Ingredient.substance.strength.textPresentation"/>
<short
value="Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)"/>
<definition
value="A textual represention of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.textPresentation"/>
<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"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:percent.concentration[x]">
<path value="Ingredient.substance.strength.concentration[x]"/>
<short value="The strength per unitary volume (or mass)"/>
<definition value="The strength per unitary volume (or mass)."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.concentration[x]"/>
<min value="0"/>
<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="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Strength.Strength (Concentration)"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:percent.concentration[x].id">
<path value="Ingredient.substance.strength.concentration[x].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="Ingredient.substance.strength:percent.concentration[x].extension">
<path value="Ingredient.substance.strength.concentration[x].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="Ingredient.substance.strength:percent.concentration[x].value">
<path value="Ingredient.substance.strength.concentration[x].value"/>
<short value="Ingredient Total Amount Content Percent"/>
<definition
value="The percentage of the component in the drug product. [Source: SME Defined]
Example: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08"/>
<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="1"/>
<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>
<mustSupport value="true"/>
<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="Ingredient.substance.strength:percent.concentration[x].comparator">
<path
value="Ingredient.substance.strength.concentration[x].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="Ingredient.substance.strength:percent.concentration[x].unit">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="Ingredient.substance.strength.concentration[x].unit"/>
<short value="Unit representation"/>
<definition value="A human-readable form of the unit."/>
<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="Ingredient.substance.strength:percent.concentration[x].system">
<path value="Ingredient.substance.strength.concentration[x].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="Ingredient.substance.strength:percent.concentration[x].code">
<path value="Ingredient.substance.strength.concentration[x].code"/>
<short value="Ingredient Total Amount Content Percent UOM"/>
<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="Ingredient.substance.strength:percent.textConcentration">
<path value="Ingredient.substance.strength.textConcentration"/>
<short
value="Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)"/>
<definition
value="A textual represention of either the whole of the concentration strength or a part of it - with the rest being in Strength.concentration as a ratio."/>
<min value="0"/>
<max value="0"/>
<base>
<path value="Ingredient.substance.strength.textConcentration"/>
<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"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:percent.basis">
<path value="Ingredient.substance.strength.basis"/>
<short
value="A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)"/>
<definition
value="A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.basis"/>
<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"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:percent.measurementPoint">
<path value="Ingredient.substance.strength.measurementPoint"/>
<short
value="When strength is measured at a particular point or distance"/>
<definition
value="For when strength is measured at a particular point or distance. There are products where strength is measured at a particular point. For example, the strength of the ingredient in some inhalers is measured at a particular position relative to the point of aerosolization."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Ingredient.substance.strength.measurementPoint"/>
<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"/>
<map value="Strength.Measurement Point"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:percent.country">
<path value="Ingredient.substance.strength.country"/>
<short value="Where the strength range applies"/>
<definition
value="The country or countries for which the strength range applies."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Ingredient.substance.strength.country"/>
<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="Country"/>
</extension>
<strength value="example"/>
<description value="Jurisdiction codes"/>
<valueSet value="http://hl7.org/fhir/ValueSet/country"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Strength.Country"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:percent.referenceStrength">
<path value="Ingredient.substance.strength.referenceStrength"/>
<short value="Strength expressed in terms of a reference substance"/>
<definition
value="Strength expressed in terms of a reference substance. For when the ingredient strength is additionally expressed as equivalent to the strength of some other closely related substance (e.g. salt vs. base). Reference strength represents the strength (quantitative composition) of the active moiety of the active substance. There are situations when the active substance and active moiety are different, therefore both a strength and a reference strength are needed."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Ingredient.substance.strength.referenceStrength"/>
<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"/>
<map value="Strength.Reference Strength"/>
</mapping>
</element>
<element id="Ingredient.substance.strength:percent.referenceStrength.id">
<path value="Ingredient.substance.strength.referenceStrength.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="Ingredient.substance.strength:percent.referenceStrength.extension">
<path
value="Ingredient.substance.strength.referenceStrength.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="Ingredient.substance.strength:percent.referenceStrength.modifierExtension">
<path
value="Ingredient.substance.strength.referenceStrength.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="Ingredient.substance.strength:percent.referenceStrength.substance">
<path
value="Ingredient.substance.strength.referenceStrength.substance"/>
<short value="Relevant reference substance"/>
<definition value="Relevant reference substance."/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="Ingredient.substance.strength.referenceStrength.substance"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="CodeableReference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"/>
</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="SNOMEDCTSubstanceCodes"/>
</extension>
<strength value="example"/>
<description
value="This value set includes all substance codes from SNOMED CT - provided as an exemplar value set."/>
<valueSet value="http://hl7.org/fhir/ValueSet/substance-codes"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Reference Strength.Reference Substance"/>
</mapping>
</element>
<element
id="Ingredient.substance.strength:percent.referenceStrength.strength[x]">
<path
value="Ingredient.substance.strength.referenceStrength.strength[x]"/>
<short value="Strength expressed in terms of a reference substance"/>
<definition
value="Strength expressed in terms of a reference substance."/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="Ingredient.substance.strength.referenceStrength.strength[x]"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Ratio"/>
</type>
<type>
<code value="RatioRange"/>
</type>
<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="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Reference Strength.Reference Strength"/>
</mapping>
</element>
<element
id="Ingredient.substance.strength:percent.referenceStrength.measurementPoint">
<path
value="Ingredient.substance.strength.referenceStrength.measurementPoint"/>
<short
value="When strength is measured at a particular point or distance"/>
<definition
value="For when strength is measured at a particular point or distance."/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="Ingredient.substance.strength.referenceStrength.measurementPoint"/>
<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"/>
<map value="Reference Strength.Measurement Point"/>
</mapping>
</element>
<element
id="Ingredient.substance.strength:percent.referenceStrength.country">
<path value="Ingredient.substance.strength.referenceStrength.country"/>
<short value="Where the strength range applies"/>
<definition
value="The country or countries for which the strength range applies."/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="Ingredient.substance.strength.referenceStrength.country"/>
<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="Country"/>
</extension>
<strength value="example"/>
<description value="Jurisdiction codes"/>
<valueSet value="http://hl7.org/fhir/ValueSet/country"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Reference Strength.Country"/>
</mapping>
</element>
</snapshot>
<differential>
<element id="Ingredient.for">
<path value="Ingredient.for"/>
<short value="Reference to MedicinalProductDefinition"/>
</element>
<element id="Ingredient.role">
<path value="Ingredient.role"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology"/>
</binding>
</element>
<element id="Ingredient.comment">
<path value="Ingredient.comment"/>
<short value="Drug Product Component Additional Information"/>
<definition
value="A placeholder for providing any comments that are relevant to the component. [Source: SME Defined]
Examples: removed during process, adjusted for loss on drying, etc."/>
<mustSupport value="true"/>
</element>
<element id="Ingredient.substance">
<path value="Ingredient.substance"/>
<constraint>
<key value="cmc-strength-type-cases2"/>
<severity value="error"/>
<human
value="IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements.
Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity."/>
<expression
value="defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(
strength
.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension')
.extension.where(
value.coding.where(
code = 'C45420' and
system = %system
).exists()
).exists()
implies (
strength.presentation.ofType(Ratio).exists() and
strength.presentation.numerator.where(
code = '[arb\'U]' and
system = 'http://unitsofmeasure.org'
)
) or (
strength.presentation.ofType(Quantity).exists() and
strength.presentation.where(
code = '[arb\'U]' and
system = 'http://unitsofmeasure.org'
)
))"/>
<source
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component"/>
</constraint>
</element>
<element id="Ingredient.substance.code">
<path value="Ingredient.substance.code"/>
<short value="Ingredient Substance"/>
<type>
<code value="CodeableReference"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference"/>
<targetProfile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"/>
<aggregation value="bundled"/>
</type>
<mustSupport value="true"/>
</element>
<element id="Ingredient.substance.strength">
<path value="Ingredient.substance.strength"/>
<slicing>
<discriminator>
<type value="exists"/>
<path value="textConcentration"/>
</discriminator>
<ordered value="false"/>
<rules value="closed"/>
</slicing>
<min value="2"/>
<max value="2"/>
<mustSupport value="true"/>
</element>
<element id="Ingredient.substance.strength:amount">
<path value="Ingredient.substance.strength"/>
<sliceName value="amount"/>
<min value="1"/>
<max value="1"/>
<mustSupport value="true"/>
</element>
<element id="Ingredient.substance.strength:amount.extension">
<path value="Ingredient.substance.strength.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<min value="1"/>
</element>
<element
id="Ingredient.substance.strength:amount.extension:strengthFactors">
<path value="Ingredient.substance.strength.extension"/>
<sliceName value="strengthFactors"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension"/>
</type>
<mustSupport value="true"/>
</element>
<element id="Ingredient.substance.strength:amount.concentration[x]">
<path value="Ingredient.substance.strength.concentration[x]"/>
<slicing>
<discriminator>
<type value="type"/>
<path value="$this"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<min value="1"/>
<type>
<code value="Ratio"/>
</type>
<type>
<code value="Quantity"/>
</type>
<mustSupport value="true"/>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity">
<path value="Ingredient.substance.strength.concentration[x]"/>
<sliceName value="concentrationQuantity"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Quantity"/>
</type>
<mustSupport value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units"/>
</binding>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.value">
<path value="Ingredient.substance.strength.concentration[x].value"/>
<short value="Ingredient Total Amount Numeric"/>
<definition
value="Specifies the quantity of an ingredient in a single dose unit (e.g., one tablet, capsule) of the drug product. [Source: SME Defined]
Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Ingredient Total Amount Numeric = 325"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator">
<path
value="Ingredient.substance.strength.concentration[x].comparator"/>
<short value="Ingredient Total Amount Operator"/>
<definition
value="A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT.
Note: This is typically applicable to biologics."/>
<mustSupport value="true"/>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.unit">
<path value="Ingredient.substance.strength.concentration[x].unit"/>
<min value="1"/>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio">
<path value="Ingredient.substance.strength.concentration[x]"/>
<sliceName value="concentrationRatio"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Ratio"/>
</type>
<mustSupport value="true"/>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator">
<path value="Ingredient.substance.strength.concentration[x].numerator"/>
<definition
value="Specifies the quantity of an ingredient in a single dose unit of the drug product. [Source: SME Defined]"/>
<min value="1"/>
<mustSupport value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units"/>
</binding>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.value">
<path
value="Ingredient.substance.strength.concentration[x].numerator.value"/>
<short value="Ingredient Total Amount Numeric Numerator"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.unit">
<path
value="Ingredient.substance.strength.concentration[x].numerator.unit"/>
<short value="Ingredient Total Amount Numeric Numerator UOM"/>
<definition
value="The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI EVS C117055]
Example: mg"/>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.code">
<path
value="Ingredient.substance.strength.concentration[x].numerator.code"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator">
<path
value="Ingredient.substance.strength.concentration[x].denominator"/>
<min value="1"/>
<mustSupport value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units"/>
</binding>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.value">
<path
value="Ingredient.substance.strength.concentration[x].denominator.value"/>
<short value="Ingredient Total Amount Numeric Denominator"/>
<definition
value="Specifies the quantity of the ingredients within a single dose unit (e.g., vial, syringe) of drug product. [Source: SME Defined]
Example: 10mg/syringe, 1mg/ml"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.unit">
<path
value="Ingredient.substance.strength.concentration[x].denominator.unit"/>
<short value="Ingredient Total Amount Numeric Denominator UOM"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element
id="Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.code">
<path
value="Ingredient.substance.strength.concentration[x].denominator.code"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="Ingredient.substance.strength:amount.textConcentration">
<path value="Ingredient.substance.strength.textConcentration"/>
<short value="Strength Textual"/>
<definition
value="A written description of the strength of the ingredient. [Source: SME Defined]"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="Ingredient.substance.strength:percent">
<path value="Ingredient.substance.strength"/>
<sliceName value="percent"/>
<min value="1"/>
<max value="1"/>
<mustSupport value="true"/>
</element>
<element id="Ingredient.substance.strength:percent.concentration[x]">
<path value="Ingredient.substance.strength.concentration[x]"/>
<min value="1"/>
<type>
<code value="Quantity"/>
</type>
<mustSupport value="true"/>
<binding>
<strength value="required"/>
<valueSet
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units"/>
</binding>
</element>
<element
id="Ingredient.substance.strength:percent.concentration[x].value">
<path value="Ingredient.substance.strength.concentration[x].value"/>
<short value="Ingredient Total Amount Content Percent"/>
<definition
value="The percentage of the component in the drug product. [Source: SME Defined]
Example: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element
id="Ingredient.substance.strength:percent.concentration[x].code">
<path value="Ingredient.substance.strength.concentration[x].code"/>
<short value="Ingredient Total Amount Content Percent UOM"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="Ingredient.substance.strength:percent.textConcentration">
<path value="Ingredient.substance.strength.textConcentration"/>
<max value="0"/>
<mustSupport value="true"/>
</element>
</differential>
</StructureDefinition>
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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