Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.2 - 1.1.2 United States of America flag

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

: 55f2bbea-1a2d-4240-aef0-bc1a76b39212 - XML Representation

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<SubstanceDefinition xmlns="http://hl7.org/fhir">
  <id value="55f2bbea-1a2d-4240-aef0-bc1a76b39212"/>
  <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="55f2bbea-1a2d-4240-aef0-bc1a76b39212"> </a><a name="hc55f2bbea-1a2d-4240-aef0-bc1a76b39212"> </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;55f2bbea-1a2d-4240-aef0-bc1a76b39212&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>: DIOXANE</p><p><b>classification</b>: Residual Solvent <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C176815)</span></p><h3>Structures</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Technique</b></td></tr><tr><td style="display: none">*</td><td>Residual Solvent <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table><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>J8A3S10O7S <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>#J8A3S10O7S)</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>DIOXANE</td><td>Generic Name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C97054)</span></td><td>true</td></tr></table></div>
  </text>
  <identifier>
    <value value="DIOXANE"/>
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  <classification>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
      <code value="C176815"/>
      <display value="Residual Solvent"/>
    </coding>
  </classification>
  <structure>
    <technique>
      <text value="Residual Solvent"/>
    </technique>
  </structure>
  <code>
    <code>
      <coding>
        <system value="http://fdasis.nlm.nih.gov"/>
        <code value="J8A3S10O7S"/>
      </coding>
    </code>
  </code>
  <name>
    <name value="DIOXANE"/>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
        <code value="C97054"/>
        <display value="Generic Name"/>
      </coding>
    </type>
    <preferred value="true"/>
  </name>
</SubstanceDefinition>