Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.2 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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: ffa30c0b-8031-436a-87f1-635b3bbe5989 - XML Representation

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<SubstanceDefinition xmlns="http://hl7.org/fhir">
  <id value="ffa30c0b-8031-436a-87f1-635b3bbe5989"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition </b><a name="ffa30c0b-8031-436a-87f1-635b3bbe5989"> </a><a name="hcffa30c0b-8031-436a-87f1-635b3bbe5989"> </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">ResourceSubstanceDefinition &quot;ffa30c0b-8031-436a-87f1-635b3bbe5989&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-drug-product-substance-impurity.html">Drug Substance Impurity</a></p></div><p><b>identifier</b>: hydroxyApatite</p><p><b>classification</b>: Degradation Product <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C176816)</span></p><blockquote><p><b>structure</b></p><p><b>technique</b>: formed from dicalcium phosphate degradation <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>: XZFUZCHOJLQYHV-UHFFFAOYSA-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>: [OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O</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>91D9GV0Z28 <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>#91D9GV0Z28)</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>TRIBASIC CALCIUM PHOSPHATE</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="hydroxyApatite"/>
  </identifier>
  <classification>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
      <code value="C176816"/>
      <display value="Degradation Product"/>
    </coding>
  </classification>
  <structure>
    <technique>
      <text value="formed from dicalcium phosphate degradation"/>
    </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="XZFUZCHOJLQYHV-UHFFFAOYSA-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="[OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O"/>
    </representation>
  </structure>
  <code>
    <code>
      <coding>
        <system value="http://fdasis.nlm.nih.gov"/>
        <code value="91D9GV0Z28"/>
      </coding>
    </code>
  </code>
  <name>
    <name value="TRIBASIC CALCIUM PHOSPHATE"/>
    <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>