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 General Properties - XML Representation

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      <!--  Substance General Properties  -->
    <Bundle xmlns="http://hl7.org/fhir">
      <id value="bundle-drug-substance-general-properties-pq-ex1"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-general-properties-pq"/>
      </meta>
      <type value="collection"/>
      <entry>
        <fullUrl value="urn:uuid:57a9af63-315d-1585-a261-0e337b289390"/>
        <resource>
          <SubstanceDefinition>
            <id value="substancedefinition-substance-drug-pq-ex1"/>
            <text>
              <status value="extensions"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_substancedefinition-substance-drug-pq-ex1"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="substancedefinition-substance-drug-pq-ex1"> </a><a name="hcsubstancedefinition-substance-drug-pq-ex1"> </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;substancedefinition-substance-drug-pq-ex1&quot; </p></div><blockquote><p><b>property</b></p><p><b>type</b>: Appearance <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-pq-example.html">Substance Property - example</a>#appearance)</span></p><p><b>value</b>: white to slightly yellow powder <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Solubility purified water (PhEur) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-pq-example.html">Substance Property - example</a>#solubility-water-pheur)</span></p><p><b>value</b>: freely soluble <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-value-pq-example.html">Substance Property Value - example</a>#sol-free &quot;Freely soluble&quot;)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>Extension - Substance Property Range PQ</b>: 23-27 mg/mL</p><p><b>type</b>: Solubility purified water (PhEur) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-pq-example.html">Substance Property - example</a>#solubility-water-pheur)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Solubility Acetone (PhEur) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-pq-example.html">Substance Property - example</a>#solubility-acetone-pheur)</span></p><p><b>value</b>: slightly soluble <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-value-pq-example.html">Substance Property Value - example</a>#sol-slight &quot;Slightly soluble&quot;)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>Extension - Substance Property Range PQ</b>: 2-3 mg/mL</p><p><b>type</b>: Solubility acetone (PhEur) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-pq-example.html">Substance Property - example</a>#solubility-acetone-pheur)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Solubility Ethanol (PhEur) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-pq-example.html">Substance Property - example</a>#solubility-ethanol-pheur)</span></p><p><b>value</b>: soluble <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-value-pq-example.html">Substance Property Value - example</a>#sol-soluble &quot;Soluble&quot;)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>Extension - Substance Property Range PQ</b>: 15-17 mg/mL</p><p><b>type</b>: Solubility ethanol (PhEur) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-pq-example.html">Substance Property - example</a>#solubility-ethanol-pheur)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Solubility at saturation in Purifed Water after 2 hours (approx) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-pq-example.html">Substance Property - example</a>#solubility-aq-water-2h-approx)</span></p><p><b>value</b>: 21 mg/mL</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Glucose solution (5%) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-pq-example.html">Substance Property - example</a>#solubility-aq-glucose-2h-approx &quot;Solubility at saturation in Glucose (5%) after 2 hours (approx)&quot;)</span></p><p><b>value</b>: 2.5 mg/mL</p></blockquote><blockquote><p><b>property</b></p><blockquote><p><b>Extension - Substance Property Parameter PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: pH (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example code pH = 'pH', stated as 'pH')</p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 1.2</p></blockquote><p><b>type</b>: Solubility as a function of pH in USP buffers <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-pq-example.html">Substance Property - example</a>#solubility-usp-ph)</span></p><p><b>value</b>: 22 mg/mL</p></blockquote><blockquote><p><b>property</b></p><blockquote><p><b>Extension - Substance Property Parameter PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: pH (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example code pH = 'pH', stated as 'pH')</p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 4.5</p></blockquote><p><b>type</b>: Solubility as a function of pH in USP buffers <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-pq-example.html">Substance Property - example</a>#solubility-usp-ph)</span></p><p><b>value</b>: 29 mg/mL</p></blockquote><blockquote><p><b>property</b></p><p><b>Extension - Substance Property Range PQ</b>: 6.7-6.8</p><blockquote><p><b>Extension - Substance Property Parameter PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Concentration (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example code concentration = 'Concentration', stated as 'Concentration')</p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 10 mg/ml</p></blockquote><blockquote><p><b>Extension - Substance Property Parameter PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Temperature (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example code temperature = 'Temperature', stated as 'Temperature')</p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 25 °C</p></blockquote><p><b>type</b>: pH in aqueous solution <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-pq-example.html">Substance Property - example</a>#ph-aq)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Hygroscopy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-pq-example.html">Substance Property - example</a>#hygroscopy)</span></p><p><b>value</b>: Hygroscopic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-substance-property-pq-example.html">Substance Property - example</a>#hygroscopy-hygroscopic)</span></p></blockquote><h3>Structures</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Stereochemistry</b></td></tr><tr><td style="display: none">*</td><td>One asymmetric center and one axis of chirality; (S,M) - enantiomer <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table><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>
            <property>
              <type>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                  <code value="appearance"/>
                  <display value="Appearance"/>
                </coding>
              </type>
              <valueCodeableConcept>
                <text value="white to slightly yellow powder"/>
              </valueCodeableConcept>
            </property>
            <property>
              <type>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                  <code value="solubility-water-pheur"/>
                  <display value="Solubility purified water (PhEur)"/>
                </coding>
              </type>
              <valueCodeableConcept>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-value-pq-example"/>
                  <code value="sol-free"/>
                  <display value="Freely soluble"/>
                </coding>
                <text value="freely soluble"/>
              </valueCodeableConcept>
            </property>
            <property>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq">
                <valueRange>
                  <low>
                    <value value="23"/>
                    <unit value="mg/mL"/>
                  </low>
                  <high>
                    <value value="27"/>
                    <unit value="mg/mL"/>
                  </high>
                </valueRange>
              </extension>
              <type>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                  <code value="solubility-water-pheur"/>
                  <display value="Solubility purified water (PhEur)"/>
                </coding>
              </type>
            </property>
            <!--  solubility acetone  -->
            <property>
              <type>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                  <code value="solubility-acetone-pheur"/>
                  <display value="Solubility Acetone (PhEur)"/>
                </coding>
              </type>
              <valueCodeableConcept>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-value-pq-example"/>
                  <code value="sol-slight"/>
                  <display value="Slightly soluble"/>
                </coding>
                <text value="slightly soluble"/>
              </valueCodeableConcept>
            </property>
            <property>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq">
                <valueRange>
                  <low>
                    <value value="2"/>
                    <unit value="mg/mL"/>
                  </low>
                  <high>
                    <value value="3"/>
                    <unit value="mg/mL"/>
                  </high>
                </valueRange>
              </extension>
              <type>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                  <code value="solubility-acetone-pheur"/>
                  <display value="Solubility acetone (PhEur)"/>
                </coding>
              </type>
            </property>
            <!--  solubility ethanol  -->
            <property>
              <type>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                  <code value="solubility-ethanol-pheur"/>
                  <display value="Solubility Ethanol (PhEur)"/>
                </coding>
              </type>
              <valueCodeableConcept>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-value-pq-example"/>
                  <code value="sol-soluble"/>
                  <display value="Soluble"/>
                </coding>
                <text value="soluble"/>
              </valueCodeableConcept>
            </property>
            <property>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq">
                <valueRange>
                  <low>
                    <value value="15"/>
                    <unit value="mg/mL"/>
                  </low>
                  <high>
                    <value value="17"/>
                    <unit value="mg/mL"/>
                  </high>
                </valueRange>
              </extension>
              <type>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                  <code value="solubility-ethanol-pheur"/>
                  <display value="Solubility ethanol (PhEur)"/>
                </coding>
              </type>
            </property>
            <!--  purified water  -->
            <property>
              <type>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                  <code value="solubility-aq-water-2h-approx"/>
                  <display
                           value="Solubility at saturation in Purifed Water after 2 hours (approx)"/>
                </coding>
              </type>
              <valueQuantity>
                <value value="21"/>
                <unit value="mg/mL"/>
              </valueQuantity>
            </property>
            <property>
              <type>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                  <code value="solubility-aq-glucose-2h-approx"/>
                  <display
                           value="Solubility at saturation in Glucose (5%) after 2 hours (approx)"/>
                </coding>
                <text value="Glucose solution (5%)"/>
              </type>
              <valueQuantity>
                <value value="2.5"/>
                <unit value="mg/mL"/>
              </valueQuantity>
            </property>
            <property>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq">
                <extension url="parameter">
                  <valueCoding>
                    <system
                            value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                    <code value="pH"/>
                    <display value="pH"/>
                  </valueCoding>
                </extension>
                <extension url="value">
                  <valueQuantity>
                    <value value="1.2"/>
                  </valueQuantity>
                </extension>
              </extension>
              <type>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                  <code value="solubility-usp-ph"/>
                  <display value="Solubility as a function of pH in USP buffers"/>
                </coding>
              </type>
              <valueQuantity>
                <value value="22"/>
                <unit value="mg/mL"/>
              </valueQuantity>
            </property>
            <property>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq">
                <extension url="parameter">
                  <valueCoding>
                    <system
                            value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                    <code value="pH"/>
                    <display value="pH"/>
                  </valueCoding>
                </extension>
                <extension url="value">
                  <valueQuantity>
                    <value value="4.5"/>
                  </valueQuantity>
                </extension>
              </extension>
              <type>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                  <code value="solubility-usp-ph"/>
                  <display value="Solubility as a function of pH in USP buffers"/>
                </coding>
              </type>
              <valueQuantity>
                <value value="29"/>
                <unit value="mg/mL"/>
              </valueQuantity>
            </property>
            <!--  pH  -->
            <property>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq">
                <valueRange>
                  <low>
                    <value value="6.7"/>
                  </low>
                  <high>
                    <value value="6.8"/>
                  </high>
                </valueRange>
              </extension>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq">
                <extension url="parameter">
                  <valueCoding>
                    <system
                            value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                    <code value="concentration"/>
                    <display value="Concentration"/>
                  </valueCoding>
                </extension>
                <extension url="value">
                  <valueQuantity>
                    <value value="10"/>
                    <unit value="mg/ml"/>
                  </valueQuantity>
                </extension>
              </extension>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq">
                <extension url="parameter">
                  <valueCoding>
                    <system
                            value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                    <code value="temperature"/>
                    <display value="Temperature"/>
                  </valueCoding>
                </extension>
                <extension url="value">
                  <valueQuantity>
                    <value value="25"/>
                    <unit value="°C"/>
                  </valueQuantity>
                </extension>
              </extension>
              <type>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                  <code value="ph-aq"/>
                  <display value="pH in aqueous solution"/>
                </coding>
              </type>
            </property>
            <property>
              <type>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                  <code value="hygroscopy"/>
                  <display value="Hygroscopy"/>
                </coding>
              </type>
              <valueCodeableConcept>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example"/>
                  <code value="hygroscopy-hygroscopic"/>
                  <display value="Hygroscopic"/>
                </coding>
                <text value="Hygroscopic"/>
              </valueCodeableConcept>
            </property>
            <structure>
              <stereochemistry>
                <text
                      value="One asymmetric center and one axis of chirality; (S,M) - enantiomer"/>
              </stereochemistry>
            </structure>
            <name>
              <name value="Stelbatolol"/>
            </name>
          </SubstanceDefinition>
        </resource>
      </entry>
    </Bundle>