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

## : Example: Bundle – Substance Specification - XML Representation

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      <!--  Substance Specification  -->
    <Bundle xmlns="http://hl7.org/fhir">
      <id value="bundle-drug-substance-specification-pq-ex1"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-specification-pq"/>
      </meta>
      <type value="collection"/>
      <entry>
        <fullUrl value="urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a"/>
        <resource>
          <PlanDefinition>
            <id value="specificationProtocol"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_specificationProtocol"> </a><p><b>Generated Narrative: PlanDefinition</b><a name="specificationProtocol"> </a><a name="hcspecificationProtocol"> </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 PlanDefinition &quot;specificationProtocol&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a</code></p><p><b>title</b>: SPECIFICATION FOR DRUG SUBSTANCE</p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: SubstanceDefinition/03d68d1c-162c-8b6e-70f9-647b0ea97adb</p><p><b>description</b>: Narrative description of specifications</p><blockquote><p><b>action</b></p><p><b>title</b>: Specification for Drug Substance</p><p><b>code</b>: Overall set of actions <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9">http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3">http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a">http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121">http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17">http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d">http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce">http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d">http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f">http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f</a></td></tr></table></blockquote></div>
            </text>
            <!-- http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a -->
            <url
                 value="http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a"/>
            <title value="SPECIFICATION FOR DRUG SUBSTANCE"/>
            <status value="active"/>
            <subjectReference>
              <!-- SubstanceDefinition/substance1 -->
              <reference
                         value="SubstanceDefinition/03d68d1c-162c-8b6e-70f9-647b0ea97adb"/>
            </subjectReference>
            <description value="Narrative description of specifications"/>
            <action>
              <!--  this is then entire thing  -->
              <title value="Specification for Drug Substance"/>
              <code>
                <text value="Overall set of actions"/>
              </code>
              <action>
                <code>
                  <text value="Test"/>
                </code>
                <!-- ObservationDefinition/Description -->
                <definitionCanonical
                                     value="http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9"/>
              </action>
              <action>
                <code>
                  <text value="Test"/>
                </code>
                <!-- ObservationDefinition/Identification -->
                <definitionCanonical
                                     value="http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3"/>
              </action>
              <action>
                <code>
                  <text value="Test"/>
                </code>
                <!-- ObservationDefinition/Assay -->
                <definitionCanonical
                                     value="http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a"/>
              </action>
              <action>
                <code>
                  <text value="Test"/>
                </code>
                <!-- ObservationDefinition/Impurities -->
                <definitionCanonical
                                     value="http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121"/>
              </action>
              <action>
                <code>
                  <text value="Test"/>
                </code>
                <!-- ObservationDefinition/Mutagenic -->
                <definitionCanonical
                                     value="http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17"/>
              </action>
              <action>
                <code>
                  <text value="Test"/>
                </code>
                <!-- ObservationDefinition/Enantiomeric -->
                <definitionCanonical
                                     value="http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d"/>
              </action>
              <action>
                <code>
                  <text value="Test"/>
                </code>
                <!-- ObservationDefinition/Solvents -->
                <definitionCanonical
                                     value="http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"/>
              </action>
              <action>
                <code>
                  <text value="Test"/>
                </code>
                <!-- ObservationDefinition/Water -->
                <definitionCanonical
                                     value="http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d"/>
              </action>
              <action>
                <code>
                  <text value="Test"/>
                </code>
                <!-- ObservationDefinition/Particles -->
                <definitionCanonical
                                     value="http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f"/>
              </action>
            </action>
          </PlanDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:52176085-1f30-0c67-9ad7-523c486c82c9"/>
        <resource>
          <ObservationDefinition>
            <!-- Description -->
            <id value="52176085-1f30-0c67-9ad7-523c486c82c9"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_52176085-1f30-0c67-9ad7-523c486c82c9"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="52176085-1f30-0c67-9ad7-523c486c82c9"> </a><a name="hc52176085-1f30-0c67-9ad7-523c486c82c9"> </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;52176085-1f30-0c67-9ad7-523c486c82c9&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9</code></p><p><b>title</b>: Description</p><p><b>status</b>: active</p><p><b>code</b>: Description <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>#DESC)</span></p><p><b>method</b>: Visual inspection <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9 -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9"/>
            <title value="Description"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="DESC"/>
                <display value="Description"/>
              </coding>
              <text value="Description"/>
            </code>
            <method>
              <text value="Visual inspection"/>
            </method>
            <qualifiedValue>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
                <valueString value="A white to brown powder"/>
              </extension>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:b50d892c-8980-0774-39d4-d449732873a3"/>
        <resource>
          <ObservationDefinition>
            <!-- Identification -->
            <id value="b50d892c-8980-0774-39d4-d449732873a3"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_b50d892c-8980-0774-39d4-d449732873a3"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="b50d892c-8980-0774-39d4-d449732873a3"> </a><a name="hcb50d892c-8980-0774-39d4-d449732873a3"> </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;b50d892c-8980-0774-39d4-d449732873a3&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <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>#IDT)</span></p><p><b>method</b>: Identification by IR spectroscopy Identification by HPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3 -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3"/>
            <title value="Identification"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="IDT"/>
                <display value="Identification"/>
              </coding>
              <text value="Identification"/>
            </code>
            <method>
              <text
                    value="Identification by IR spectroscopy Identification by HPLC"/>
            </method>
            <qualifiedValue>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
                <valueString value="Conforms with reference"/>
              </extension>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:d460b561-110c-7eb6-5d69-788abcca391a"/>
        <resource>
          <ObservationDefinition>
            <!-- Assay -->
            <id value="d460b561-110c-7eb6-5d69-788abcca391a"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_d460b561-110c-7eb6-5d69-788abcca391a"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="d460b561-110c-7eb6-5d69-788abcca391a"> </a><a name="hcd460b561-110c-7eb6-5d69-788abcca391a"> </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;d460b561-110c-7eb6-5d69-788abcca391a&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <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>#ASSAY)</span></p><p><b>method</b>: Assay by LC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>98-102 % w/w</td></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a"/>
            <title value="Assay"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="ASSAY"/>
                <display value="Assay"/>
              </coding>
              <text value="Assay"/>
            </code>
            <method>
              <text value="Assay by LC"/>
            </method>
            <qualifiedValue>
              <range>
                <low>
                  <value value="98"/>
                  <unit value="% w/w"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </low>
                <high>
                  <value value="102"/>
                  <unit value="% w/w"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </high>
              </range>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:006a9f7b-91ca-5601-38ef-a3dd26ad7121"/>
        <resource>
          <ObservationDefinition>
            <!-- Impurities -->
            <id value="006a9f7b-91ca-5601-38ef-a3dd26ad7121"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_006a9f7b-91ca-5601-38ef-a3dd26ad7121"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="006a9f7b-91ca-5601-38ef-a3dd26ad7121"> </a><a name="hc006a9f7b-91ca-5601-38ef-a3dd26ad7121"> </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;006a9f7b-91ca-5601-38ef-a3dd26ad7121&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121</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>: 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>
            <!-- http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121 -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121"/>
            <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>
                <!--  could be a code  -->
                <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="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>
              <!--  are expected to have a component that says what impurity this one is  -->
              <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>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:c59deb1b-835c-1be5-4e08-95dea3ae1a17"/>
        <resource>
          <ObservationDefinition>
            <!-- Mutagenic -->
            <id value="c59deb1b-835c-1be5-4e08-95dea3ae1a17"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_c59deb1b-835c-1be5-4e08-95dea3ae1a17"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="c59deb1b-835c-1be5-4e08-95dea3ae1a17"> </a><a name="hcc59deb1b-835c-1be5-4e08-95dea3ae1a17"> </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;c59deb1b-835c-1be5-4e08-95dea3ae1a17&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17</code></p><p><b>title</b>: Mutagenic impurities</p><p><b>status</b>: active</p><p><b>code</b>: Mutagenic 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>#MUT)</span></p><p><b>method</b>: Impurity 5 content by LC-MS <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>AppliesTo</b></td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>Impurity - Mutagenic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>?-50</td></tr></table><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>
            <!-- http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17 -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17"/>
            <title value="Mutagenic impurities"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="MUT"/>
                <display value="Mutagenic impurities"/>
              </coding>
            </code>
            <method>
              <text value="Impurity 5 content by LC-MS"/>
            </method>
            <qualifiedValue>
              <appliesTo>
                <!--  could be a code  -->
                <text value="Impurity - Mutagenic"/>
              </appliesTo>
              <range>
                <high>
                  <value value="50"/>
                  <unit value="ppm"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="[ppm]"/>
                </high>
              </range>
            </qualifiedValue>
            <component>
              <!--  are expected to have a component that says what impurity this one is  -->
              <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>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:18e20bae-1a24-202d-11d7-5f354c785e4d"/>
        <resource>
          <ObservationDefinition>
            <!-- Enantiomeric -->
            <id value="18e20bae-1a24-202d-11d7-5f354c785e4d"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_18e20bae-1a24-202d-11d7-5f354c785e4d"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="18e20bae-1a24-202d-11d7-5f354c785e4d"> </a><a name="hc18e20bae-1a24-202d-11d7-5f354c785e4d"> </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;18e20bae-1a24-202d-11d7-5f354c785e4d&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d</code></p><p><b>title</b>: Enantiomeric purity</p><p><b>status</b>: active</p><p><b>code</b>: Enantiomeric purity <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>#enantiomeric-purity)</span></p><p><b>method</b>: Enantiomeric purity by LC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>99.6-? %</td></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d"/>
            <title value="Enantiomeric purity"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="enantiomeric-purity"/>
                <display value="Enantiomeric purity"/>
              </coding>
              <text value="Enantiomeric purity"/>
            </code>
            <method>
              <text value="Enantiomeric purity by LC"/>
            </method>
            <qualifiedValue>
              <range>
                <low>
                  <value value="99.6"/>
                  <unit value="%"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </low>
              </range>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"/>
        <resource>
          <ObservationDefinition>
            <!-- Solvents -->
            <id value="22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"> </a><a name="hc22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"> </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;22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce</code></p><p><b>title</b>: Residual solvents</p><p><b>status</b>: active</p><p><b>code</b>: Residual solvents <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>#SOL)</span></p><p><b>method</b>: Residual solvents by headspace GC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Solvent 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.1</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Solvent 2 <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>Solvent <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>#SOLV)</span></td></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"/>
            <title value="Residual solvents"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="SOL"/>
                <display value="Residual solvents"/>
              </coding>
            </code>
            <method>
              <text value="Residual solvents by headspace GC"/>
            </method>
            <qualifiedValue>
              <appliesTo>
                <!--  could be a code  -->
                <text value="Solvent 1"/>
              </appliesTo>
              <range>
                <high>
                  <value value="0.1"/>
                  <unit value="% w/w"/>
                </high>
              </range>
            </qualifiedValue>
            <qualifiedValue>
              <appliesTo>
                <text value="Solvent 2"/>
              </appliesTo>
              <range>
                <high>
                  <value value="2.0"/>
                  <unit value="% w/w"/>
                </high>
              </range>
            </qualifiedValue>
            <component>
              <!--  are expected to have a component that says what solvent this one is  -->
              <code>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                  <code value="SOLV"/>
                  <display value="Solvent"/>
                </coding>
              </code>
            </component>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:b4f736ff-1bbf-6923-4d5c-85d262285d7d"/>
        <resource>
          <ObservationDefinition>
            <!-- Water -->
            <id value="b4f736ff-1bbf-6923-4d5c-85d262285d7d"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_b4f736ff-1bbf-6923-4d5c-85d262285d7d"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="b4f736ff-1bbf-6923-4d5c-85d262285d7d"> </a><a name="hcb4f736ff-1bbf-6923-4d5c-85d262285d7d"> </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;b4f736ff-1bbf-6923-4d5c-85d262285d7d&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d</code></p><p><b>title</b>: Water Content</p><p><b>status</b>: active</p><p><b>code</b>: Water Content <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>#WaterContent)</span></p><p><b>method</b>: USP Karl Fischer titration <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>?-1.0</td></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d"/>
            <title value="Water Content"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="WaterContent"/>
                <display value="Water Content"/>
              </coding>
              <text value="Water Content"/>
            </code>
            <method>
              <text value="USP Karl Fischer titration"/>
            </method>
            <qualifiedValue>
              <range>
                <high>
                  <value value="1.0"/>
                  <unit value="% w/w"/>
                </high>
              </range>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:233865df-2a71-528d-756c-85f36bd6685f"/>
        <resource>
          <ObservationDefinition>
            <!-- Particles -->
            <id value="233865df-2a71-528d-756c-85f36bd6685f"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_233865df-2a71-528d-756c-85f36bd6685f"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="233865df-2a71-528d-756c-85f36bd6685f"> </a><a name="hc233865df-2a71-528d-756c-85f36bd6685f"> </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;233865df-2a71-528d-756c-85f36bd6685f&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f</code></p><p><b>title</b>: Particle size distribution</p><p><b>status</b>: active</p><p><b>code</b>: Particle size distribution <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>#particle-size-distribution)</span></p><p><b>method</b>: Laser diffraction <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: D(v,0.9) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-319</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: D(v,0.5) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-145</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: D(v,0.1) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-20</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>Particle size <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>#particle-size)</span></td></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f"/>
            <title value="Particle size distribution"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="particle-size-distribution"/>
                <display value="Particle size distribution"/>
              </coding>
            </code>
            <method>
              <text value="Laser diffraction"/>
            </method>
            <qualifiedValue>
              <appliesTo>
                <!--  could be a code  -->
                <text value="D(v,0.9)"/>
              </appliesTo>
              <range>
                <high>
                  <value value="319"/>
                  <unit value="µm"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="um"/>
                </high>
              </range>
            </qualifiedValue>
            <qualifiedValue>
              <appliesTo>
                <!--  could be a code  -->
                <text value="D(v,0.5)"/>
              </appliesTo>
              <range>
                <high>
                  <value value="145"/>
                  <unit value="µm"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="um"/>
                </high>
              </range>
            </qualifiedValue>
            <qualifiedValue>
              <appliesTo>
                <!--  could be a code  -->
                <text value="D(v,0.1)"/>
              </appliesTo>
              <range>
                <high>
                  <value value="20"/>
                  <unit value="µm"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="um"/>
                </high>
              </range>
            </qualifiedValue>
            <component>
              <!--  are expected to have a component that says what solvent this one is  -->
              <code>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                  <code value="particle-size"/>
                  <display value="Particle size"/>
                </coding>
              </code>
            </component>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:03d68d1c-162c-8b6e-70f9-647b0ea97adb"/>
        <resource>
          <SubstanceDefinition>
            <!-- substance1 -->
            <id value="03d68d1c-162c-8b6e-70f9-647b0ea97adb"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_03d68d1c-162c-8b6e-70f9-647b0ea97adb"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="03d68d1c-162c-8b6e-70f9-647b0ea97adb"> </a><a name="hc03d68d1c-162c-8b6e-70f9-647b0ea97adb"> </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;03d68d1c-162c-8b6e-70f9-647b0ea97adb&quot; </p></div><p><b>manufacturer</b>: See on this page: Organization/062bf235-44e2-55c4-9213-bbe5e12d5620</p><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td>Stelbatolol</td></tr></table></div>
            </text>
            <manufacturer>
              <!-- Organization/substance-manufacturer -->
              <reference
                         value="Organization/062bf235-44e2-55c4-9213-bbe5e12d5620"/>
            </manufacturer>
            <name>
              <name value="Stelbatolol"/>
            </name>
          </SubstanceDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:062bf235-44e2-55c4-9213-bbe5e12d5620"/>
        <resource>
          <Organization>
            <!-- substance-manufacturer -->
            <id value="062bf235-44e2-55c4-9213-bbe5e12d5620"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_062bf235-44e2-55c4-9213-bbe5e12d5620"> </a><p><b>Generated Narrative: Organization</b><a name="062bf235-44e2-55c4-9213-bbe5e12d5620"> </a><a name="hc062bf235-44e2-55c4-9213-bbe5e12d5620"> </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 Organization &quot;062bf235-44e2-55c4-9213-bbe5e12d5620&quot; </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3003040516</p><p><b>active</b>: true</p><p><b>type</b>: Drug Substance Manufacture <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-organization-type.html">Pharmaceutical Organization Type Codes</a>#drug-substance-manufacture)</span></p><p><b>name</b>: AAA Molybdenum Products, Inc.</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>
            </text>
            <identifier>
              <!--  FDA establishment identifier  -->
              <system value="urn:oid:2.16.840.1.113883.4.82"/>
              <value value="3003040516"/>
            </identifier>
            <active value="true"/>
            <type>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type"/>
                <code value="drug-substance-manufacture"/>
                <display value="Drug Substance Manufacture"/>
              </coding>
            </type>
            <name value="AAA Molybdenum Products, Inc."/>
            <contact>
              <address>
                <line value="7233 W 116th Pl"/>
                <line value="Ste C"/>
                <city value="Broomfield"/>
                <state value="Colorado"/>
                <postalCode value="80020"/>
                <country value="USA"/>
              </address>
            </contact>
          </Organization>
        </resource>
      </entry>
    </Bundle>