Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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

: ddd3abad-347c-4d2f-95f3-dd804e250502 - XML Representation

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<MedicinalProductDefinition xmlns="http://hl7.org/fhir">
  <id value="ddd3abad-347c-4d2f-95f3-dd804e250502"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: MedicinalProductDefinition </b><a name="ddd3abad-347c-4d2f-95f3-dd804e250502"> </a><a name="hcddd3abad-347c-4d2f-95f3-dd804e250502"> </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">ResourceMedicinalProductDefinition &quot;ddd3abad-347c-4d2f-95f3-dd804e250502&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-drug-product-with-impurities.html">Drug Product Impurities</a></p></div><p><b>identifier</b>: TabletCoatedBeadsCoatedAll</p><p><b>description</b>: A drug product composed of one type of bead with two coatings inside a coated tablet</p><p><b>combinedPharmaceuticalDoseForm</b>: TABLET, MULTILAYER <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C42964)</span></p><h3>Impurities</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-9e8f2d16-66b1-47ec-878d-f50ae021985b.html#urn-uuid-58ae52aa-c81e-415a-8791-e67a3195290d">urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d</a></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-9e8f2d16-66b1-47ec-878d-f50ae021985b.html#urn-uuid-ffa30c0b-8031-436a-87f1-635b3bbe5989">urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989</a></td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: LEVOTHYROXINE SODIUM ANHYDROUS 125mg</p><p><b>type</b>: Non-Proprietary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-product-name-types.html">Product Name Types Code Types</a>#NON)</span></p><blockquote><p><b>part</b></p><p><b>part</b>: LEVOTHYROXINE SODIUM ANHYDROUS</p><p><b>type</b>: scientific name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html">EntityNamePartQualifierR2</a>#SCI)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 125mg</p><p><b>type</b>: LEVOTHYROXINE SODIUM ANHYDROUS <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html">EntityNamePartQualifierR2</a>#STR)</span></p></blockquote></blockquote></div>
  </text>
  <identifier>
    <value value="TabletCoatedBeadsCoatedAll"/>
  </identifier>
  <description
               value="A drug product composed of one type of bead with two coatings inside a coated tablet"/>
  <combinedPharmaceuticalDoseForm>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
      <code value="C42964"/>
      <display value="TABLET, MULTILAYER"/>
    </coding>
  </combinedPharmaceuticalDoseForm>
  <impurity>
    <reference>
      <reference value="urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d"/>
    </reference>
  </impurity>
  <impurity>
    <reference>
      <reference value="urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989"/>
    </reference>
  </impurity>
  <name>
    <productName value="LEVOTHYROXINE SODIUM ANHYDROUS 125mg"/>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types"/>
        <code value="NON"/>
        <display value="Non-Proprietary"/>
      </coding>
      <text value="Non-Proprietary"/>
    </type>
    <part>
      <part value="LEVOTHYROXINE SODIUM ANHYDROUS"/>
      <type>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
          <code value="SCI"/>
        </coding>
      </type>
    </part>
    <part>
      <part value="125mg"/>
      <type>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
          <code value="STR"/>
        </coding>
        <text value="LEVOTHYROXINE SODIUM ANHYDROUS"/>
      </type>
    </part>
  </name>
</MedicinalProductDefinition>