Pharmaceutical Quality (Industry)
1.0.0 - STU1

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. 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><a name="hcImpurities"> </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://example-server.com/fhir/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-example.html">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-example.html">Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>
      </text>
      <url
           value="http://example-server.com/fhir/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-example"/>
          <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-example"/>
            <code value="IMP"/>
            <display value="Impurity"/>
          </coding>
        </code>
      </component>
    </ObservationDefinition>