Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

: Polymorphic Form Example - XML Representation

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<SubstanceDefinition xmlns="http://hl7.org/fhir">
  <id value="832f22b4-6f0c-41f8-9b7d-f26f55e9973c"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="832f22b4-6f0c-41f8-9b7d-f26f55e9973c"> </a><a name="hc832f22b4-6f0c-41f8-9b7d-f26f55e9973c"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource SubstanceDefinition &quot;832f22b4-6f0c-41f8-9b7d-f26f55e9973c&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-polymorphic-form.html">Polymorphic Form</a></p></div><p><b>identifier</b>: DextroThyroxine</p><blockquote><p><b>structure</b></p><p><b>molecularFormula</b>: C15H10I4NO4.Na.H2O</p><blockquote><p><b>representation</b></p><p><b>type</b>: InChI File (small molecule) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C54683)</span></p><p><b>representation</b>: ANMYAHDLKVNJJO-CURYUGHLSA-M</p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: SMILES <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C54684)</span></p><p><b>representation</b>: O.[Na+].N[C@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O</p></blockquote><blockquote><p><b>representation</b></p><p><b>document</b>: <a href="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3">urn:uuid:0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3</a></p></blockquote></blockquote><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>0H00N2AHSP <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html">Unique Ingredient Identifier (UNII)</a>#0H00N2AHSP)</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>DEXTROTHYROXINE SODIUM</td><td>GSRS Preferred Term <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C203355)</span></td><td>true</td></tr></table></div>
  </text>
  <identifier>
    <value value="DextroThyroxine"/>
  </identifier>
  <structure>
    <molecularFormula value="C15H10I4NO4.Na.H2O"/>
    <representation>
      <type>
        <coding>
          <system
                  value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
          <code value="C54683"/>
          <display value="InChI File (small molecule)"/>
        </coding>
      </type>
      <representation value="ANMYAHDLKVNJJO-CURYUGHLSA-M"/>
    </representation>
    <representation>
      <type>
        <coding>
          <system
                  value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
          <code value="C54684"/>
          <display value="SMILES"/>
        </coding>
      </type>
      <representation
                      value="O.[Na+].N[C@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O"/>
    </representation>
    <representation>
      <document>
        <reference value="urn:uuid:0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3"/>
      </document>
    </representation>
  </structure>
  <code>
    <code>
      <coding>
        <system value="http://fdasis.nlm.nih.gov"/>
        <code value="0H00N2AHSP"/>
      </coding>
    </code>
  </code>
  <name>
    <name value="DEXTROTHYROXINE SODIUM"/>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
        <code value="C203355"/>
        <display value="GSRS Preferred Term"/>
      </coding>
    </type>
    <preferred value="true"/>
  </name>
</SubstanceDefinition>