Pharmaceutical Quality (Industry)
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This page is part of the Pharmaceutical Quality (Industry) (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

: Impurities - XML Representation

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<ObservationDefinition xmlns="http://hl7.org/fhir">
  <!--  Contained in Accumulus FHIR Substance Example - Batch Analysis (05-31-2023)  -->
  <id value="Impurities"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="Impurities"> </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 ObservationDefinition &quot;Impurities&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ObservationDefinition-test-method-drug-pq.html">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/Impurities</code></p><p><b>title</b>: Drug Substance Related Organic impurities</p><p><b>status</b>: active</p><p><b>code</b>: Drug Substance Related Organic impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP-s)</span></p><p><b>method</b>: Organic impurities by LC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.5</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.5</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.5</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Any individual unspecified impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.10</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-2.0</p></blockquote><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>
  </text>
  <url
       value="http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/Impurities"/>
  <title value="Drug Substance Related Organic impurities"/>
  <status value="active"/>
  <code>
    <coding>
      <system
              value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
      <code value="DGP-s"/>
      <display value="Drug Substance Related Organic impurities"/>
    </coding>
  </code>
  <method>
    <text value="Organic impurities by LC"/>
  </method>
  <qualifiedValue>
    <appliesTo>
      <text value="Impurity 1"/>
    </appliesTo>
    <range>
      <high>
        <value value="0.5"/>
        <unit value="% w/w"/>
      </high>
    </range>
  </qualifiedValue>
  <qualifiedValue>
    <appliesTo>
      <text value="Impurity 2"/>
    </appliesTo>
    <range>
      <high>
        <value value="0.5"/>
        <unit value="% w/w"/>
      </high>
    </range>
  </qualifiedValue>
  <qualifiedValue>
    <appliesTo>
      <text value="Impurity 3">
        <extension
                   url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq">
          <!--                      <extension url="http://accumulus.org/fhir/extension/testComment"> -->
          <valueString
                       value="Impurity 3 was included in the release specification throughout clinical development, and no longer forms a part of a commercial release specification; see Section S.4.5 Justification of Specification and Section S.2.5 Validation (PPQ) for additional data"/>
        </extension>
      </text>
    </appliesTo>
    <range>
      <high>
        <value value="0.5"/>
        <unit value="% w/w"/>
      </high>
    </range>
  </qualifiedValue>
  <qualifiedValue>
    <appliesTo>
      <text value="Any individual unspecified impurity"/>
    </appliesTo>
    <range>
      <high>
        <value value="0.10"/>
        <unit value="% w/w"/>
      </high>
    </range>
  </qualifiedValue>
  <qualifiedValue>
    <appliesTo>
      <text value="Total impurities"/>
    </appliesTo>
    <range>
      <high>
        <value value="2.0"/>
        <unit value="% w/w"/>
      </high>
    </range>
  </qualifiedValue>
  <component>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
        <code value="IMP"/>
        <display value="Impurity"/>
      </coding>
    </code>
  </component>
</ObservationDefinition>