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

: 278736ef-2ddf-49e4-895c-3a9f34db36cf - XML Representation

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<SubstanceDefinition xmlns="http://hl7.org/fhir">
  <id value="278736ef-2ddf-49e4-895c-3a9f34db36cf"/>
  <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"><p><b>Generated Narrative: SubstanceDefinition</b><a name="278736ef-2ddf-49e4-895c-3a9f34db36cf"> </a><a name="hc278736ef-2ddf-49e4-895c-3a9f34db36cf"> </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;278736ef-2ddf-49e4-895c-3a9f34db36cf&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-excipient.html">Excipient Drug Substance</a></p></div><p><b>identifier</b>: Cochineal</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>grade</b>: Company Standard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134009)</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>TZ8Z31B35M <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>#TZ8Z31B35M)</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>Cochineal</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><h3>SourceMaterials</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Genus</b></td><td><b>Species</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style="display: none">*</td><td>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></td><td>Dactylopius <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>cochineal <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>Turkey <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-ISO3166Part1.html">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#TUR)</span></td></tr></table></div>
  </text>
  <identifier>
    <value value="Cochineal"/>
  </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>
  <grade>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
      <code value="C134009"/>
      <display value="Company Standard"/>
    </coding>
  </grade>
  <code>
    <code>
      <coding>
        <system value="http://fdasis.nlm.nih.gov"/>
        <code value="TZ8Z31B35M"/>
      </coding>
    </code>
  </code>
  <name>
    <name value="Cochineal"/>
    <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>
  <sourceMaterial>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
        <code value="C48807"/>
        <display value="Chemical"/>
      </coding>
    </type>
    <genus>
      <text value="Dactylopius"/>
    </genus>
    <species>
      <text value="cochineal"/>
    </species>
    <countryOfOrigin>
      <coding>
        <system value="urn:iso:std:iso:3166"/>
        <code value="TUR"/>
        <display value="Turkey"/>
      </coding>
    </countryOfOrigin>
  </sourceMaterial>
</SubstanceDefinition>