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
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<title value="Batch formula example"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><p class="res-header-id"><b>Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a</b></p><a name="4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><a name="hc4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><a name="4f3e9af1-306b-4fad-bf04-7881400b266a-en-US"> </a><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Wunderwerke</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478</td></tr></table></div>
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<identifier>
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<code value="C134003"/>
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<text
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<entry>
<fullUrl value="urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501"/>
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<Organization>
<id value="e875ef93-a730-4c44-bead-53663ae7f501"/>
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<profile
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<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_e875ef93-a730-4c44-bead-53663ae7f501"> </a><p class="res-header-id"><b>Generated Narrative: Organization e875ef93-a730-4c44-bead-53663ae7f501</b></p><a name="e875ef93-a730-4c44-bead-53663ae7f501"> </a><a name="hce875ef93-a730-4c44-bead-53663ae7f501"> </a><a name="e875ef93-a730-4c44-bead-53663ae7f501-en-US"> </a><p><b>identifier</b>: DUNS/143265222, FEI/6981397</p><p><b>name</b>: East-West Manufacturing</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>East-West Manufacturing, 100 Stillwater Avenue, Building #2, Bangor, ME, United States</td></tr></table></div>
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<identifier>
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<system
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<code value="C134003"/>
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<name value="East-West Manufacturing"/>
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<address>
<type value="postal"/>
<text
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<line value="100 Stillwater Avenue"/>
<line value="Building #2"/>
<city value="Bangor"/>
<state value="ME"/>
<postalCode value="04401"/>
<country value="USA"/>
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<entry>
<fullUrl value="urn:uuid:d0d2df25-5cfa-4417-b8d1-b8147957f53c"/>
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<MedicinalProductDefinition>
<id value="d0d2df25-5cfa-4417-b8d1-b8147957f53c"/>
<meta>
<profile
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_d0d2df25-5cfa-4417-b8d1-b8147957f53c"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition d0d2df25-5cfa-4417-b8d1-b8147957f53c</b></p><a name="d0d2df25-5cfa-4417-b8d1-b8147957f53c"> </a><a name="hcd0d2df25-5cfa-4417-b8d1-b8147957f53c"> </a><a name="d0d2df25-5cfa-4417-b8d1-b8147957f53c-en-US"> </a><p><b>identifier</b>: Oxazepam-Propranolol-BatchFormula-Identification</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42953}">LIQUID</span></p><p><b>route</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38288}">ORAL</span></p><p><b>comprisedOf</b>: <a href="Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-249ef22b-d521-4304-a388-6b9035f97b22">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></p><blockquote><p><b>name</b></p><p><b>productName</b>: ATOMOXETINE HYDROCHLORIDE 1mg</p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C96971}">Nonproprietary Name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: ATOMOXETINE HYDROCHLORIDE</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 1mg</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}">ATOMOXETINE HYDROCHLORIDE</span></p></blockquote></blockquote></div>
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<code value="C42953"/>
<display value="LIQUID"/>
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<code value="C38288"/>
<display value="ORAL"/>
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<comprisedOf>
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<name>
<productName value="ATOMOXETINE HYDROCHLORIDE 1mg"/>
<type>
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<code value="C96971"/>
<display value="Nonproprietary Name"/>
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<part>
<part value="ATOMOXETINE HYDROCHLORIDE"/>
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<code value="SCI"/>
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<part value="1mg"/>
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<text value="ATOMOXETINE HYDROCHLORIDE"/>
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<fullUrl value="urn:uuid:249ef22b-d521-4304-a388-6b9035f97b22"/>
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<ManufacturedItemDefinition>
<id value="249ef22b-d521-4304-a388-6b9035f97b22"/>
<meta>
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<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_249ef22b-d521-4304-a388-6b9035f97b22"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition 249ef22b-d521-4304-a388-6b9035f97b22</b></p><a name="249ef22b-d521-4304-a388-6b9035f97b22"> </a><a name="hc249ef22b-d521-4304-a388-6b9035f97b22"> </a><a name="249ef22b-d521-4304-a388-6b9035f97b22-en-US"> </a><p><b>identifier</b>: Oxazepam-Propranolol-BatchFormula</p><p><b>status</b>: Active</p><p><b>name</b>: ATOMOXETINE HYDROCHLORIDE 1mg</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45298}">Liquid</span></p><p><b>manufacturer</b>: <a href="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-e875ef93-a730-4c44-bead-53663ae7f501">Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000</a></p><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Batch Quantity</span></p><p><b>value</b>: 50 liter<span style="background: LightGoldenRodYellow"> (Details: UCUM codeL = 'L')</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Batch Utilization</span></p><p><b>value</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C133990}">Commercial</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Product Part Additional Information</span></p><p><b>value</b>: </p><div><p>Makes 50 Litres of product, accounting for losses from evaporation and spillage</p>
</div></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42986}">Solution</span></p><p><b>amount</b>: 53.2 kilogram<span style="background: LightGoldenRodYellow"> (Details: UCUM codekg = 'kg')</span>, 100 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><blockquote><p><b>constituent</b></p><p><b>Product Batch Strength Textual Extension</b>: 5% atomexetine hydrochloride solution</p><p><b>amount</b>: 25.42 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span>, 0.0477 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><h3>HasIngredients</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-1c1a2a23-1fd7-4487-9682-49877f9f9f77">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 20.5 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span>, 0.0385 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><h3>HasIngredients</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-12cce82f-8595-4860-b7ca-06c9ec0327f2">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 5 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span>, 0.0094 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><h3>HasIngredients</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-45eb4f05-83d9-4819-bb60-96c7c5ce2b76">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 2.27 kilogram<span style="background: LightGoldenRodYellow"> (Details: UCUM codekg = 'kg')</span>, 4.2652 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><h3>HasIngredients</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-29c0ee76-f62f-41d3-b761-73d5f205e552">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 150 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span>, 0.2818 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><h3>HasIngredients</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-44fad9fd-826a-4f0c-9f25-e0a78d1c4269">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 50.75 kilogram<span style="background: LightGoldenRodYellow"> (Details: UCUM codekg = 'kg')</span>, 95.3572 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><h3>HasIngredients</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-d0574580-7694-4a36-8a27-5bdbccfc5557">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><h3>Properties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Product Part Identifier</span></td><td><span title="Codes:">solution</span></td></tr></table></blockquote></div>
</text>
<identifier>
<value value="Oxazepam-Propranolol-BatchFormula"/>
</identifier>
<status value="active"/>
<name value="ATOMOXETINE HYDROCHLORIDE 1mg"/>
<manufacturedDoseForm>
<coding>
<system
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<code value="C45298"/>
<display value="Liquid"/>
</coding>
</manufacturedDoseForm>
<manufacturer>
<reference value="urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501"/>
</manufacturer>
<property>
<type>
<text value="Batch Quantity"/>
</type>
<valueQuantity>
<value value="50"/>
<unit value="liter"/>
<system value="http://unitsofmeasure.org"/>
<code value="L"/>
</valueQuantity>
</property>
<property>
<type>
<text value="Batch Utilization"/>
</type>
<valueCodeableConcept>
<coding>
<system
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<code value="C133990"/>
<display value="Commercial"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<text value="Product Part Additional Information"/>
</type>
<valueMarkdown
value="Makes 50 Litres of product, accounting for losses from evaporation and spillage"/>
</property>
<component>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C42986"/>
<display value="Solution"/>
</coding>
</type>
<amount>
<value value="53.2"/>
<unit value="kilogram"/>
<system value="http://unitsofmeasure.org"/>
<code value="kg"/>
</amount>
<amount>
<value value="100"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<constituent>
<extension
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<valueString value="5% atomexetine hydrochloride solution"/>
</extension>
<amount>
<value value="25.42"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</amount>
<amount>
<value value="0.0477"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<hasIngredient>
<reference>
<reference
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</reference>
</hasIngredient>
</constituent>
<constituent>
<amount>
<value value="20.5"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</amount>
<amount>
<value value="0.0385"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<hasIngredient>
<reference>
<reference
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</reference>
</hasIngredient>
</constituent>
<constituent>
<amount>
<value value="5"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</amount>
<amount>
<value value="0.0094"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<hasIngredient>
<reference>
<reference
value="urn:uuid:45eb4f05-83d9-4819-bb60-96c7c5ce2b76"/>
</reference>
</hasIngredient>
</constituent>
<constituent>
<amount>
<value value="2.27"/>
<unit value="kilogram"/>
<system value="http://unitsofmeasure.org"/>
<code value="kg"/>
</amount>
<amount>
<value value="4.2652"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<hasIngredient>
<reference>
<reference
value="urn:uuid:29c0ee76-f62f-41d3-b761-73d5f205e552"/>
</reference>
</hasIngredient>
</constituent>
<constituent>
<amount>
<value value="150"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</amount>
<amount>
<value value="0.2818"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<hasIngredient>
<reference>
<reference
value="urn:uuid:44fad9fd-826a-4f0c-9f25-e0a78d1c4269"/>
</reference>
</hasIngredient>
</constituent>
<constituent>
<amount>
<value value="50.75"/>
<unit value="kilogram"/>
<system value="http://unitsofmeasure.org"/>
<code value="kg"/>
</amount>
<amount>
<value value="95.3572"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</amount>
<hasIngredient>
<reference>
<reference
value="urn:uuid:d0574580-7694-4a36-8a27-5bdbccfc5557"/>
</reference>
</hasIngredient>
</constituent>
<property>
<type>
<text value="Product Part Identifier"/>
</type>
<valueCodeableConcept>
<text value="solution"/>
</valueCodeableConcept>
</property>
</component>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:1c1a2a23-1fd7-4487-9682-49877f9f9f77"/>
<resource>
<Ingredient>
<id value="1c1a2a23-1fd7-4487-9682-49877f9f9f77"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_1c1a2a23-1fd7-4487-9682-49877f9f9f77"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 1c1a2a23-1fd7-4487-9682-49877f9f9f77</b></p><a name="1c1a2a23-1fd7-4487-9682-49877f9f9f77"> </a><a name="hc1c1a2a23-1fd7-4487-9682-49877f9f9f77"> </a><a name="1c1a2a23-1fd7-4487-9682-49877f9f9f77-en-US"> </a><p><b>identifier</b>: AtomexetineHydrochlorideBFIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C82533}">Active Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-717d868e-6696-4ebb-adf4-63eadb3bf058">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 25.42 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 0.0477 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>
</text>
<identifier>
<value value="AtomexetineHydrochlorideBFIngredient"/>
</identifier>
<status value="active"/>
<role>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C82533"/>
<display value="Active Ingredient"/>
</coding>
</role>
<substance>
<code>
<reference>
<reference
value="urn:uuid:717d868e-6696-4ebb-adf4-63eadb3bf058"/>
</reference>
</code>
<strength>
<concentrationQuantity>
<value value="25.42"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</concentrationQuantity>
</strength>
<strength>
<concentrationQuantity>
<value value="0.0477"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</concentrationQuantity>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:717d868e-6696-4ebb-adf4-63eadb3bf058"/>
<resource>
<SubstanceDefinition>
<id value="717d868e-6696-4ebb-adf4-63eadb3bf058"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_717d868e-6696-4ebb-adf4-63eadb3bf058"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition 717d868e-6696-4ebb-adf4-63eadb3bf058</b></p><a name="717d868e-6696-4ebb-adf4-63eadb3bf058"> </a><a name="hc717d868e-6696-4ebb-adf4-63eadb3bf058"> </a><a name="717d868e-6696-4ebb-adf4-63eadb3bf058-en-US"> </a><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}">USP-NF</span></p><p><b>manufacturer</b>: <a href="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-e875ef93-a730-4c44-bead-53663ae7f501">Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000</a></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov 57WVB6I2W0}">57WVB6I2W0</span></td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style="display: none">*</td><td>ATOMOXETINE HYDROCHLORIDE</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></td><td>true</td></tr></table></div>
</text>
<classification>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134006"/>
<display value="USP-NF"/>
</coding>
</grade>
<manufacturer>
<reference value="urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501"/>
</manufacturer>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="57WVB6I2W0"/>
</coding>
</code>
</code>
<name>
<name value="ATOMOXETINE HYDROCHLORIDE"/>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:12cce82f-8595-4860-b7ca-06c9ec0327f2"/>
<resource>
<Ingredient>
<id value="12cce82f-8595-4860-b7ca-06c9ec0327f2"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_12cce82f-8595-4860-b7ca-06c9ec0327f2"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 12cce82f-8595-4860-b7ca-06c9ec0327f2</b></p><a name="12cce82f-8595-4860-b7ca-06c9ec0327f2"> </a><a name="hc12cce82f-8595-4860-b7ca-06c9ec0327f2"> </a><a name="12cce82f-8595-4860-b7ca-06c9ec0327f2-en-US"> </a><p><b>identifier</b>: GlacialAceticAcidBFIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-45942749-64db-4f91-88c3-51adb680fed1">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 20.5 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 0.0385 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>
</text>
<identifier>
<value value="GlacialAceticAcidBFIngredient"/>
</identifier>
<status value="active"/>
<role>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C42637"/>
<display value="Inactive Ingredient"/>
</coding>
</role>
<substance>
<code>
<reference>
<reference
value="urn:uuid:45942749-64db-4f91-88c3-51adb680fed1"/>
</reference>
</code>
<strength>
<concentrationQuantity>
<value value="20.5"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</concentrationQuantity>
</strength>
<strength>
<concentrationQuantity>
<value value="0.0385"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</concentrationQuantity>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:45942749-64db-4f91-88c3-51adb680fed1"/>
<resource>
<SubstanceDefinition>
<id value="45942749-64db-4f91-88c3-51adb680fed1"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_45942749-64db-4f91-88c3-51adb680fed1"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition 45942749-64db-4f91-88c3-51adb680fed1</b></p><a name="45942749-64db-4f91-88c3-51adb680fed1"> </a><a name="hc45942749-64db-4f91-88c3-51adb680fed1"> </a><a name="45942749-64db-4f91-88c3-51adb680fed1-en-US"> </a><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}">USP-NF</span></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov Q40Q9N063P}">Q40Q9N063P</span></td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style="display: none">*</td><td>ACETIC ACID</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></td></tr></table></div>
</text>
<classification>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134006"/>
<display value="USP-NF"/>
</coding>
</grade>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="Q40Q9N063P"/>
</coding>
</code>
</code>
<name>
<name value="ACETIC ACID"/>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
<sourceMaterial>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</type>
</sourceMaterial>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:45eb4f05-83d9-4819-bb60-96c7c5ce2b76"/>
<resource>
<Ingredient>
<id value="45eb4f05-83d9-4819-bb60-96c7c5ce2b76"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_45eb4f05-83d9-4819-bb60-96c7c5ce2b76"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 45eb4f05-83d9-4819-bb60-96c7c5ce2b76</b></p><a name="45eb4f05-83d9-4819-bb60-96c7c5ce2b76"> </a><a name="hc45eb4f05-83d9-4819-bb60-96c7c5ce2b76"> </a><a name="45eb4f05-83d9-4819-bb60-96c7c5ce2b76-en-US"> </a><p><b>identifier</b>: AnhydrousSodiumAcetateBFIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-07c598ee-3dcf-45b7-b4e5-b24812c22aff">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 5 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 0.0094 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>
</text>
<identifier>
<value value="AnhydrousSodiumAcetateBFIngredient"/>
</identifier>
<status value="active"/>
<role>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C42637"/>
<display value="Inactive Ingredient"/>
</coding>
</role>
<substance>
<code>
<reference>
<reference
value="urn:uuid:07c598ee-3dcf-45b7-b4e5-b24812c22aff"/>
</reference>
</code>
<strength>
<concentrationQuantity>
<value value="5"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</concentrationQuantity>
</strength>
<strength>
<concentrationQuantity>
<value value="0.0094"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</concentrationQuantity>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:07c598ee-3dcf-45b7-b4e5-b24812c22aff"/>
<resource>
<SubstanceDefinition>
<id value="07c598ee-3dcf-45b7-b4e5-b24812c22aff"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_07c598ee-3dcf-45b7-b4e5-b24812c22aff"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition 07c598ee-3dcf-45b7-b4e5-b24812c22aff</b></p><a name="07c598ee-3dcf-45b7-b4e5-b24812c22aff"> </a><a name="hc07c598ee-3dcf-45b7-b4e5-b24812c22aff"> </a><a name="07c598ee-3dcf-45b7-b4e5-b24812c22aff-en-US"> </a><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}">USP-NF</span></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov NVG71ZZ7P0}">NVG71ZZ7P0</span></td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style="display: none">*</td><td>SODIUM ACETATE ANHYDROUS</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></td></tr></table></div>
</text>
<classification>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134006"/>
<display value="USP-NF"/>
</coding>
</grade>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="NVG71ZZ7P0"/>
</coding>
</code>
</code>
<name>
<name value="SODIUM ACETATE ANHYDROUS"/>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
<sourceMaterial>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</type>
</sourceMaterial>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:29c0ee76-f62f-41d3-b761-73d5f205e552"/>
<resource>
<Ingredient>
<id value="29c0ee76-f62f-41d3-b761-73d5f205e552"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_29c0ee76-f62f-41d3-b761-73d5f205e552"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 29c0ee76-f62f-41d3-b761-73d5f205e552</b></p><a name="29c0ee76-f62f-41d3-b761-73d5f205e552"> </a><a name="hc29c0ee76-f62f-41d3-b761-73d5f205e552"> </a><a name="29c0ee76-f62f-41d3-b761-73d5f205e552-en-US"> </a><p><b>identifier</b>: MannitolBFIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-a339a562-e325-4ce6-a830-d25c27b5e2da">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 2.27 kilogram<span style="background: LightGoldenRodYellow"> (Details: UCUM codekg = 'kg')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 4.2652 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>
</text>
<identifier>
<value value="MannitolBFIngredient"/>
</identifier>
<status value="active"/>
<role>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C42637"/>
<display value="Inactive Ingredient"/>
</coding>
</role>
<substance>
<code>
<reference>
<reference
value="urn:uuid:a339a562-e325-4ce6-a830-d25c27b5e2da"/>
</reference>
</code>
<strength>
<concentrationQuantity>
<value value="2.27"/>
<unit value="kilogram"/>
<system value="http://unitsofmeasure.org"/>
<code value="kg"/>
</concentrationQuantity>
</strength>
<strength>
<concentrationQuantity>
<value value="4.2652"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</concentrationQuantity>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:a339a562-e325-4ce6-a830-d25c27b5e2da"/>
<resource>
<SubstanceDefinition>
<id value="a339a562-e325-4ce6-a830-d25c27b5e2da"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_a339a562-e325-4ce6-a830-d25c27b5e2da"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition a339a562-e325-4ce6-a830-d25c27b5e2da</b></p><a name="a339a562-e325-4ce6-a830-d25c27b5e2da"> </a><a name="hca339a562-e325-4ce6-a830-d25c27b5e2da"> </a><a name="a339a562-e325-4ce6-a830-d25c27b5e2da-en-US"> </a><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}">USP-NF</span></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov 3OWL53L36A}">3OWL53L36A</span></td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style="display: none">*</td><td>MANNITOL</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></td></tr></table></div>
</text>
<classification>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134006"/>
<display value="USP-NF"/>
</coding>
</grade>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="3OWL53L36A"/>
</coding>
</code>
</code>
<name>
<name value="MANNITOL"/>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
<sourceMaterial>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</type>
</sourceMaterial>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:44fad9fd-826a-4f0c-9f25-e0a78d1c4269"/>
<resource>
<Ingredient>
<id value="44fad9fd-826a-4f0c-9f25-e0a78d1c4269"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_44fad9fd-826a-4f0c-9f25-e0a78d1c4269"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 44fad9fd-826a-4f0c-9f25-e0a78d1c4269</b></p><a name="44fad9fd-826a-4f0c-9f25-e0a78d1c4269"> </a><a name="hc44fad9fd-826a-4f0c-9f25-e0a78d1c4269"> </a><a name="44fad9fd-826a-4f0c-9f25-e0a78d1c4269-en-US"> </a><p><b>identifier</b>: MetacresolBFIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-c75df5fb-e962-43a6-9dd3-c6682da10a7e">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 150 gram<span style="background: LightGoldenRodYellow"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 0.2818 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>
</text>
<identifier>
<value value="MetacresolBFIngredient"/>
</identifier>
<status value="active"/>
<role>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C42637"/>
<display value="Inactive Ingredient"/>
</coding>
</role>
<substance>
<code>
<reference>
<reference
value="urn:uuid:c75df5fb-e962-43a6-9dd3-c6682da10a7e"/>
</reference>
</code>
<strength>
<concentrationQuantity>
<value value="150"/>
<unit value="gram"/>
<system value="http://unitsofmeasure.org"/>
<code value="g"/>
</concentrationQuantity>
</strength>
<strength>
<concentrationQuantity>
<value value="0.2818"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</concentrationQuantity>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:c75df5fb-e962-43a6-9dd3-c6682da10a7e"/>
<resource>
<SubstanceDefinition>
<id value="c75df5fb-e962-43a6-9dd3-c6682da10a7e"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_c75df5fb-e962-43a6-9dd3-c6682da10a7e"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition c75df5fb-e962-43a6-9dd3-c6682da10a7e</b></p><a name="c75df5fb-e962-43a6-9dd3-c6682da10a7e"> </a><a name="hcc75df5fb-e962-43a6-9dd3-c6682da10a7e"> </a><a name="c75df5fb-e962-43a6-9dd3-c6682da10a7e-en-US"> </a><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}">USP-NF</span></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov GGO4Y809LO}">GGO4Y809LO</span></td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style="display: none">*</td><td>METACRESOL</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></td></tr></table></div>
</text>
<classification>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134006"/>
<display value="USP-NF"/>
</coding>
</grade>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="GGO4Y809LO"/>
</coding>
</code>
</code>
<name>
<name value="METACRESOL"/>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
<sourceMaterial>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</type>
</sourceMaterial>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:d0574580-7694-4a36-8a27-5bdbccfc5557"/>
<resource>
<Ingredient>
<id value="d0574580-7694-4a36-8a27-5bdbccfc5557"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_d0574580-7694-4a36-8a27-5bdbccfc5557"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient d0574580-7694-4a36-8a27-5bdbccfc5557</b></p><a name="d0574580-7694-4a36-8a27-5bdbccfc5557"> </a><a name="hcd0574580-7694-4a36-8a27-5bdbccfc5557"> </a><a name="d0574580-7694-4a36-8a27-5bdbccfc5557-en-US"> </a><p><b>identifier</b>: WaterBFIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-c4e5b7c6-2e52-48e3-813b-d227cf29329b">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 50.75 kilogram<span style="background: LightGoldenRodYellow"> (Details: UCUM codekg = 'kg')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 95.3572 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>
</text>
<identifier>
<value value="WaterBFIngredient"/>
</identifier>
<status value="active"/>
<role>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C42637"/>
<display value="Inactive Ingredient"/>
</coding>
</role>
<substance>
<code>
<reference>
<reference
value="urn:uuid:c4e5b7c6-2e52-48e3-813b-d227cf29329b"/>
</reference>
</code>
<strength>
<concentrationQuantity>
<value value="50.75"/>
<unit value="kilogram"/>
<system value="http://unitsofmeasure.org"/>
<code value="kg"/>
</concentrationQuantity>
</strength>
<strength>
<concentrationQuantity>
<value value="95.3572"/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</concentrationQuantity>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:c4e5b7c6-2e52-48e3-813b-d227cf29329b"/>
<resource>
<SubstanceDefinition>
<id value="c4e5b7c6-2e52-48e3-813b-d227cf29329b"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_c4e5b7c6-2e52-48e3-813b-d227cf29329b"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition c4e5b7c6-2e52-48e3-813b-d227cf29329b</b></p><a name="c4e5b7c6-2e52-48e3-813b-d227cf29329b"> </a><a name="hcc4e5b7c6-2e52-48e3-813b-d227cf29329b"> </a><a name="c4e5b7c6-2e52-48e3-813b-d227cf29329b-en-US"> </a><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}">USP-NF</span></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov 059QF0KO0R}">059QF0KO0R</span></td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style="display: none">*</td><td>WATER</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></td></tr></table></div>
</text>
<classification>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134006"/>
<display value="USP-NF"/>
</coding>
</grade>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="059QF0KO0R"/>
</coding>
</code>
</code>
<name>
<name value="WATER"/>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
<sourceMaterial>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</type>
</sourceMaterial>
</SubstanceDefinition>
</resource>
</entry>
</Bundle>
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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