Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
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
<!-- 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-characterization-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"><p><b>Generated Narrative: SubstanceDefinition</b><a name="substancedefinition-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 "substancedefinition-substance-drug-pq-ex1" </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-local-pq.html">CodeSystem - Substance Property</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-local-pq.html">CodeSystem - Substance Property</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-solubility-local-pq.html">CodeSystem - Substance Property Solubility</a>#sol-free "Freely soluble")</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-local-pq.html">CodeSystem - Substance Property</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-local-pq.html">CodeSystem - Substance Property</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-solubility-local-pq.html">CodeSystem - Substance Property Solubility</a>#sol-slight "Slightly soluble")</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-local-pq.html">CodeSystem - Substance Property</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-local-pq.html">CodeSystem - Substance Property</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-solubility-local-pq.html">CodeSystem - Substance Property Solubility</a>#sol-soluble "Soluble")</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-local-pq.html">CodeSystem - Substance Property</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-local-pq.html">CodeSystem - Substance Property</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-local-pq.html">CodeSystem - Substance Property</a>#solubility-aq-glucose-2h-approx "Solubility at saturation in Glucose (5%) after 2 hours (approx)")</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-local-pq 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-local-pq.html">CodeSystem - Substance Property</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-local-pq 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-local-pq.html">CodeSystem - Substance Property</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-local-pq 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-local-pq 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-local-pq.html">CodeSystem - Substance Property</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-local-pq.html">CodeSystem - Substance Property</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-local-pq.html">CodeSystem - Substance Property</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-local-pq"/>
<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-local-pq"/>
<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-solubility-local-pq"/>
<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-local-pq"/>
<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-local-pq"/>
<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-solubility-local-pq"/>
<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-local-pq"/>
<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-local-pq"/>
<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-solubility-local-pq"/>
<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-local-pq"/>
<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-local-pq"/>
<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-local-pq"/>
<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-local-pq"/>
<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-local-pq"/>
<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-local-pq"/>
<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-local-pq"/>
<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-local-pq"/>
<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-local-pq"/>
<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-local-pq"/>
<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-local-pq"/>
<code value="hygroscopy"/>
<display value="Hygroscopy"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq"/>
<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>
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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