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

: Drug Substance Nomenclature and Structure - XML Representation

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<SubstanceDefinition xmlns="http://hl7.org/fhir">
  <id value="21b6b724-507e-4cf4-a462-93334b98d166"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="21b6b724-507e-4cf4-a462-93334b98d166"> </a><a name="hc21b6b724-507e-4cf4-a462-93334b98d166"> </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;21b6b724-507e-4cf4-a462-93334b98d166&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure.html">Substance General Information</a></p></div><p><b>identifier</b>: levoThyroxine</p><p><b>classification</b>: Chemical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></p><p><b>manufacturer</b>: <a href="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-e875ef93-a730-4c44-bead-53663ae7f501">urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501</a></p><p><b>supplier</b>: <a href="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-e165f057-5eed-4e64-8328-4438fc88fb1b">urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b</a></p><h3>MolecularWeights</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Amount</b></td></tr><tr><td style="display: none">*</td><td>798.85 u<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C41127 = 'u')</span></td></tr></table><blockquote><p><b>structure</b></p><p><b>technique</b>: NMR Spectroscopy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></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>: YDTFRJLNMPSCFM-YDALLXLXSA-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>: [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-d94ad7ac-b935-432f-bc68-312b6b8dcca7">urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7</a></p></blockquote><blockquote><p><b>representation</b></p><p><b>document</b>: <a href="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-22bd989e-8056-494f-9bc1-195d13428179">urn:uuid:22bd989e-8056-494f-9bc1-195d13428179</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>054I36CPMN <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>#054I36CPMN)</span></td></tr></table><blockquote><p><b>name</b></p><p><b>name</b>: LEVOTHYROXINE SODIUM ANHYDROUS</p><p><b>type</b>: 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></p><p><b>preferred</b>: true</p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: sodium;(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate</p><p><b>type</b>: IUPAC Name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C203356)</span></p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: 55-03-8</p><p><b>type</b>: CAS Number <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C54682)</span></p></blockquote><h3>Relationships</h3><table class="grid"><tr><td style="display: none">-</td><td><b>SubstanceDefinition[x]</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-832f22b4-6f0c-41f8-9b7d-f26f55e9973c">urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973c</a></td><td>Polymorph <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></div>
  </text>
  <identifier>
    <value value="levoThyroxine"/>
  </identifier>
  <classification>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
      <code value="C48807"/>
      <display value="Chemical"/>
    </coding>
  </classification>
  <manufacturer>
    <reference value="urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501"/>
  </manufacturer>
  <supplier>
    <reference value="urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b"/>
  </supplier>
  <molecularWeight>
    <amount>
      <value value="798.85"/>
      <unit value="u"/>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
      <code value="C41127"/>
    </amount>
  </molecularWeight>
  <structure>
    <technique>
      <text value="NMR Spectroscopy"/>
    </technique>
    <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="YDTFRJLNMPSCFM-YDALLXLXSA-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="[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:d94ad7ac-b935-432f-bc68-312b6b8dcca7"/>
      </document>
    </representation>
    <representation>
      <document>
        <reference value="urn:uuid:22bd989e-8056-494f-9bc1-195d13428179"/>
      </document>
    </representation>
  </structure>
  <code>
    <code>
      <coding>
        <system value="http://fdasis.nlm.nih.gov"/>
        <code value="054I36CPMN"/>
      </coding>
    </code>
  </code>
  <name>
    <name value="LEVOTHYROXINE SODIUM ANHYDROUS"/>
    <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>
  <name>
    <name
          value="sodium;(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate"/>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
        <code value="C203356"/>
        <display value="IUPAC Name"/>
      </coding>
    </type>
  </name>
  <name>
    <name value="55-03-8"/>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
        <code value="C54682"/>
        <display value="CAS Number"/>
      </coding>
    </type>
  </name>
  <relationship>
    <substanceDefinitionReference>
      <reference value="urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973c"/>
    </substanceDefinitionReference>
    <type>
      <text value="Polymorph"/>
    </type>
  </relationship>
</SubstanceDefinition>