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
<Bundle xmlns="http://hl7.org/fhir">
<!-- Substance Impurities -->
<id value="bundle-product-impurities-pq-ex2-sub"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-impurities-pq"/>
</meta>
<type value="collection"/>
<entry>
<fullUrl value="urn:uuid:03d68d1c-162c-8b6e-70f9-647b0ea97adb"/>
<resource>
<SubstanceDefinition>
<id value="substance1"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="substance1"> </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 "substance1" </p></div><p><b>manufacturer</b>: <a href="#Organization_062bf235-44e2-55c4-9213-bbe5e12d5620">See above (Organization/062bf235-44e2-55c4-9213-bbe5e12d5620)</a></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><blockquote><p><b>relationship</b></p><p><b>Extension - Impurity Origin PQ</b>: Enantiomer of API SM <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-impurity-origin-local-pq.html">CodeSystem - Impurity Origin</a>#enantiomer "Enantiomer")</span></p><p><b>substanceDefinition</b>: <a href="#SubstanceDefinition_03d68d1c-162c-8b6e-80f9-647b0ea97ad1">See above (SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad1)</a></p><p><b>type</b>: Impurity Of <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-substance-relationship-type.html">Substance Relationship Type</a>#Impurity; <a href="CodeSystem-cs-impurity-type-local-pq.html">CodeSystem - Impurity Type</a>#CH-IMP "Chiral Impurity")</span></p><p><b>amount</b>: ND</p></blockquote><blockquote><p><b>relationship</b></p><p><b>Extension - Impurity Origin PQ</b>: Step 1a Process Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-impurity-origin-local-pq.html">CodeSystem - Impurity Origin</a>#process "Process Impurity")</span></p><p><b>substanceDefinition</b>: <a href="#SubstanceDefinition_03d68d1c-162c-8b6e-80f9-647b0ea97ad2">See above (SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad2)</a></p><p><b>type</b>: Impurity Of <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-substance-relationship-type.html">Substance Relationship Type</a>#Impurity; <a href="CodeSystem-cs-impurity-type-local-pq.html">CodeSystem - Impurity Type</a>#PR-IMP "Process impurity")</span></p><p><b>amount</b>: Range: ND-0.2%</p></blockquote><blockquote><p><b>relationship</b></p><p><b>Extension - Impurity Origin PQ</b>: Step 1a Process Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-impurity-origin-local-pq.html">CodeSystem - Impurity Origin</a>#process "Process Impurity")</span></p><p><b>substanceDefinition</b>: <a href="#SubstanceDefinition_03d68d1c-162c-8b6e-80f9-647b0ea97ad9">See above (SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad9)</a></p><p><b>type</b>: Impurity Of <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-substance-relationship-type.html">Substance Relationship Type</a>#Impurity; <a href="CodeSystem-cs-impurity-type-local-pq.html">CodeSystem - Impurity Type</a>#PR-IMP "Process impurity")</span></p><p><b>amount</b>: Range: ND–0.3%</p></blockquote><blockquote><p><b>relationship</b></p><p><b>Extension - Impurity Origin PQ</b>: API Starting Material <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-impurity-origin-local-pq.html">CodeSystem - Impurity Origin</a>#starting-material "Starting Material")</span></p><p><b>substanceDefinition</b>: <a href="#SubstanceDefinition_03d68d1c-162c-8b6e-80f9-647b0ea97ad3">See above (SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad3)</a></p><p><b>type</b>: Impurity Of <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-substance-relationship-type.html">Substance Relationship Type</a>#Impurity; <a href="CodeSystem-cs-impurity-type-local-pq.html">CodeSystem - Impurity Type</a>#ST-IMP "Starting material, forced degradation product")</span></p><p><b>amount</b>: Observed only during stress studies</p></blockquote><blockquote><p><b>relationship</b></p><p><b>Extension - Impurity Origin PQ</b>: API Process Intermediate <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-impurity-origin-local-pq.html">CodeSystem - Impurity Origin</a>#intermediate-material "Intermediate Material")</span></p><p><b>substanceDefinition</b>: <a href="#SubstanceDefinition_03d68d1c-162c-8b6e-80f9-647b0ea97ad4">See above (SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad4)</a></p><p><b>type</b>: Impurity Of <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-substance-relationship-type.html">Substance Relationship Type</a>#Impurity; <a href="CodeSystem-cs-impurity-type-local-pq.html">CodeSystem - Impurity Type</a>#INT-IMP "Process intermediate, forced degradation product")</span></p><p><b>amount</b>: Observed only during stress studies</p></blockquote></div>
</text>
<manufacturer>
<!-- Organization/substance-manufacturer -->
<reference
value="Organization/062bf235-44e2-55c4-9213-bbe5e12d5620"/>
</manufacturer>
<name>
<name value="Stelbatolol"/>
</name>
<relationship>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-impurity-origin-pq">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-impurity-origin-local-pq"/>
<code value="enantiomer"/>
<display value="Enantiomer"/>
</coding>
<text value="Enantiomer of API SM"/>
</valueCodeableConcept>
</extension>
<substanceDefinitionReference>
<!-- SubstanceDefinition/impurityEnantiomer -->
<reference
value="SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad1"/>
</substanceDefinitionReference>
<type>
<!-- two codes here, one is more specialised than the other -->
<coding>
<system
value="http://hl7.org/fhir/substance-relationship-type"/>
<code value="Impurity"/>
<display value="Impurity Of"/>
</coding>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-impurity-type-local-pq"/>
<code value="CH-IMP"/>
<display value="Chiral Impurity"/>
</coding>
</type>
<amountString value="ND"/>
</relationship>
<relationship>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-impurity-origin-pq">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-impurity-origin-local-pq"/>
<code value="process"/>
<display value="Process Impurity"/>
</coding>
<text value="Step 1a Process Impurity"/>
</valueCodeableConcept>
</extension>
<substanceDefinitionReference>
<!-- SubstanceDefinition/impurity1 -->
<reference
value="SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad2"/>
</substanceDefinitionReference>
<type>
<coding>
<system
value="http://hl7.org/fhir/substance-relationship-type"/>
<code value="Impurity"/>
<display value="Impurity Of"/>
</coding>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-impurity-type-local-pq"/>
<code value="PR-IMP"/>
<display value="Process impurity"/>
</coding>
</type>
<amountString value="Range: ND-0.2%"/>
</relationship>
<relationship>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-impurity-origin-pq">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-impurity-origin-local-pq"/>
<code value="process"/>
<display value="Process Impurity"/>
</coding>
<text value="Step 1a Process Impurity"/>
</valueCodeableConcept>
</extension>
<substanceDefinitionReference>
<!-- SubstanceDefinition/impurity2 -->
<reference
value="SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad9"/>
</substanceDefinitionReference>
<type>
<coding>
<system
value="http://hl7.org/fhir/substance-relationship-type"/>
<code value="Impurity"/>
<display value="Impurity Of"/>
</coding>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-impurity-type-local-pq"/>
<code value="PR-IMP"/>
<display value="Process impurity"/>
</coding>
</type>
<amountString value="Range: ND–0.3%"/>
</relationship>
<relationship>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-impurity-origin-pq">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-impurity-origin-local-pq"/>
<code value="starting-material"/>
<display value="Starting Material"/>
</coding>
<text value="API Starting Material"/>
</valueCodeableConcept>
</extension>
<substanceDefinitionReference>
<!-- SubstanceDefinition/impurityNapthol -->
<reference
value="SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad3"/>
</substanceDefinitionReference>
<type>
<coding>
<system
value="http://hl7.org/fhir/substance-relationship-type"/>
<code value="Impurity"/>
<display value="Impurity Of"/>
</coding>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-impurity-type-local-pq"/>
<code value="ST-IMP"/>
<display value="Starting material, forced degradation product"/>
</coding>
</type>
<amountString value="Observed only during stress studies"/>
</relationship>
<relationship>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-impurity-origin-pq">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-impurity-origin-local-pq"/>
<code value="intermediate-material"/>
<display value="Intermediate Material"/>
</coding>
<text value="API Process Intermediate"/>
</valueCodeableConcept>
</extension>
<substanceDefinitionReference>
<!-- SubstanceDefinition/impurityPropanol -->
<reference
value="SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad4"/>
</substanceDefinitionReference>
<type>
<coding>
<system
value="http://hl7.org/fhir/substance-relationship-type"/>
<code value="Impurity"/>
<display value="Impurity Of"/>
</coding>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-impurity-type-local-pq"/>
<code value="INT-IMP"/>
<display
value="Process intermediate, forced degradation product"/>
</coding>
</type>
<amountString value="Observed only during stress studies"/>
</relationship>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:03d68d1c-162c-8b6e-80f9-647b0ea97ad1"/>
<resource>
<SubstanceDefinition>
<!-- impurityEnantiomer -->
<id value="03d68d1c-162c-8b6e-80f9-647b0ea97ad1"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="03d68d1c-162c-8b6e-80f9-647b0ea97ad1"> </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 "03d68d1c-162c-8b6e-80f9-647b0ea97ad1" </p></div><blockquote><p><b>characterization</b></p><p><b>technique</b>: Enantiomeric purity by LC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>characterization</b></p><p><b>technique</b>: Mass spectrometry <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Rule-based (Q)Sar <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#1233444)</span></p><p><b>value</b>: Negative <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicity-local-pq.html">CodeSystem - Mutagenicity</a>#negative)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Statistical (Q)Sar <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#123555)</span></p><p><b>value</b>: Negative <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicity-local-pq.html">CodeSystem - Mutagenicity</a>#negative)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: ICH M7 Classification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#123556)</span></p><p><b>value</b>: Class 5 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-ich-m7-classification-local-pq.html">CodeSystem - ICH M7 Classification</a>#class-5)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Mutagenicity Comment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#123557)</span></p><p><b>value</b>: Treated as non-mutagenic due to lack of alerting structure <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><h3>MolecularWeights</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Amount</b></td></tr><tr><td style="display: none">*</td><td>295.80 g/mole<span style="background: LightGoldenRodYellow"> (Details: UCUM code g/mol = 'g/mol')</span></td></tr></table><blockquote><p><b>structure</b></p><h3>Representations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Document</b></td></tr><tr><td style="display: none">*</td><td><a href="#DocumentReference_13d68d1c-162c-8b6e-80f9-647b0ea97ad1">See above (DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad1)</a></td></tr></table></blockquote><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>R-enantiomer of stelbatalol</td></tr></table></div>
</text>
<characterization>
<technique>
<text value="Enantiomeric purity by LC"/>
</technique>
</characterization>
<characterization>
<technique>
<text value="Mass spectrometry"/>
</technique>
</characterization>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="1233444"/>
<display value="Rule-based (Q)Sar"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicity-local-pq"/>
<code value="negative"/>
<display value="Negative"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="123555"/>
<display value="Statistical (Q)Sar"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicity-local-pq"/>
<code value="negative"/>
<display value="Negative"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="123556"/>
<display value="ICH M7 Classification"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-ich-m7-classification-local-pq"/>
<code value="class-5"/>
<display value="Class 5"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="123557"/>
<display value="Mutagenicity Comment"/>
</coding>
</type>
<valueCodeableConcept>
<text
value="Treated as non-mutagenic due to lack of alerting structure"/>
</valueCodeableConcept>
</property>
<molecularWeight>
<amount>
<value value="295.80"/>
<unit value="g/mole"/>
<system value="http://unitsofmeasure.org"/>
<code value="g/mol"/>
</amount>
</molecularWeight>
<structure>
<representation>
<document>
<!-- DocumentReference/impurityEnantiomerdoc -->
<reference
value="DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad1"/>
</document>
</representation>
</structure>
<name>
<name value="R-enantiomer of stelbatalol"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:13d68d1c-162c-8b6e-80f9-647b0ea97ad1"/>
<resource>
<DocumentReference>
<!-- impurityEnantiomerdoc -->
<id value="13d68d1c-162c-8b6e-80f9-647b0ea97ad1"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: DocumentReference</b><a name="13d68d1c-162c-8b6e-80f9-647b0ea97ad1"> </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 DocumentReference "13d68d1c-162c-8b6e-80f9-647b0ea97ad1" </p></div><p><b>status</b>: current</p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Data</b></td></tr><tr><td style="display: none">*</td><td>image/x-png</td><td>(base64 data - 4429 bytes)</td></tr></table></blockquote></div>
</text>
<status value="current"/>
<content>
<attachment>
<contentType value="image/x-png"/>
<data
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<entry>
<fullUrl value="urn:uuid:03d68d1c-162c-8b6e-80f9-647b0ea97ad2"/>
<resource>
<SubstanceDefinition>
<!-- impurity1 -->
<id value="03d68d1c-162c-8b6e-80f9-647b0ea97ad2"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="03d68d1c-162c-8b6e-80f9-647b0ea97ad2"> </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 "03d68d1c-162c-8b6e-80f9-647b0ea97ad2" </p></div><h3>Characterizations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Technique</b></td></tr><tr><td style="display: none">*</td><td>Organic impurities by HPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table><blockquote><p><b>property</b></p><p><b>type</b>: Rule-based (Q)Sar <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#1233444)</span></p><p><b>value</b>: Negative <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicity-local-pq.html">CodeSystem - Mutagenicity</a>#negative)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Statistical (Q)Sar <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#123555)</span></p><p><b>value</b>: Negative <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicity-local-pq.html">CodeSystem - Mutagenicity</a>#negative)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: ICH M7 Classification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#123556)</span></p><p><b>value</b>: Class 5 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-ich-m7-classification-local-pq.html">CodeSystem - ICH M7 Classification</a>#class-5)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Mutagenicity Comment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#123557)</span></p><p><b>value</b>: Treated as non-mutagenic due to lack of alerting structure <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><h3>MolecularWeights</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Amount</b></td></tr><tr><td style="display: none">*</td><td>344.4 g/mole<span style="background: LightGoldenRodYellow"> (Details: UCUM code g/mol = 'g/mol')</span></td></tr></table><blockquote><p><b>structure</b></p><h3>Representations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Document</b></td></tr><tr><td style="display: none">*</td><td><a href="#DocumentReference_13d68d1c-162c-8b6e-80f9-647b0ea97ad2">See above (DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad2)</a></td></tr></table></blockquote><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>Impurity 1</td></tr></table></div>
</text>
<characterization>
<technique>
<text value="Organic impurities by HPLC"/>
</technique>
</characterization>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="1233444"/>
<display value="Rule-based (Q)Sar"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicity-local-pq"/>
<code value="negative"/>
<display value="Negative"/>
</coding>
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<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="123555"/>
<display value="Statistical (Q)Sar"/>
</coding>
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<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicity-local-pq"/>
<code value="negative"/>
<display value="Negative"/>
</coding>
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<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="123556"/>
<display value="ICH M7 Classification"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-ich-m7-classification-local-pq"/>
<code value="class-5"/>
<display value="Class 5"/>
</coding>
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<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="123557"/>
<display value="Mutagenicity Comment"/>
</coding>
</type>
<valueCodeableConcept>
<text
value="Treated as non-mutagenic due to lack of alerting structure"/>
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<molecularWeight>
<amount>
<value value="344.4"/>
<unit value="g/mole"/>
<system value="http://unitsofmeasure.org"/>
<code value="g/mol"/>
</amount>
</molecularWeight>
<structure>
<representation>
<document>
<!-- DocumentReference/impurity1doc -->
<reference
value="DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad2"/>
</document>
</representation>
</structure>
<name>
<name value="Impurity 1"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:13d68d1c-162c-8b6e-80f9-647b0ea97ad2"/>
<resource>
<DocumentReference>
<!-- impurity1doc -->
<id value="13d68d1c-162c-8b6e-80f9-647b0ea97ad2"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: DocumentReference</b><a name="13d68d1c-162c-8b6e-80f9-647b0ea97ad2"> </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 DocumentReference "13d68d1c-162c-8b6e-80f9-647b0ea97ad2" </p></div><p><b>status</b>: current</p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Data</b></td></tr><tr><td style="display: none">*</td><td>image/x-png</td><td>(base64 data - 7004 bytes)</td></tr></table></blockquote></div>
</text>
<status value="current"/>
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<attachment>
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="03d68d1c-162c-8b6e-80f9-647b0ea97ad9"> </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 "03d68d1c-162c-8b6e-80f9-647b0ea97ad9" </p></div><h3>Characterizations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Technique</b></td></tr><tr><td style="display: none">*</td><td>Organic impurities by LC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table><blockquote><p><b>property</b></p><p><b>type</b>: Rule-based (Q)Sar <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#1233444)</span></p><p><b>value</b>: Negative <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicity-local-pq.html">CodeSystem - Mutagenicity</a>#negative)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Statistical (Q)Sar <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#123555)</span></p><p><b>value</b>: Negative <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicity-local-pq.html">CodeSystem - Mutagenicity</a>#negative)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: ICH M7 Classification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#123556)</span></p><p><b>value</b>: Class 5 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-ich-m7-classification-local-pq.html">CodeSystem - ICH M7 Classification</a>#class-5)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Mutagenicity Comment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#123557)</span></p><p><b>value</b>: Treated as non-mutagenic due to lack of alerting structure <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><h3>MolecularWeights</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Amount</b></td></tr><tr><td style="display: none">*</td><td>459.58 g/mole<span style="background: LightGoldenRodYellow"> (Details: UCUM code g/mol = 'g/mol')</span></td></tr></table><blockquote><p><b>structure</b></p><h3>Representations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Document</b></td></tr><tr><td style="display: none">*</td><td><a href="#DocumentReference_13d68d1c-162c-8b6e-80f9-647b0ea97ad9">See above (DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad9)</a></td></tr></table></blockquote><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>Impurity 2</td></tr></table></div>
</text>
<characterization>
<technique>
<text value="Organic impurities by LC"/>
</technique>
</characterization>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="1233444"/>
<display value="Rule-based (Q)Sar"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicity-local-pq"/>
<code value="negative"/>
<display value="Negative"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="123555"/>
<display value="Statistical (Q)Sar"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicity-local-pq"/>
<code value="negative"/>
<display value="Negative"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="123556"/>
<display value="ICH M7 Classification"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-ich-m7-classification-local-pq"/>
<code value="class-5"/>
<display value="Class 5"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="123557"/>
<display value="Mutagenicity Comment"/>
</coding>
</type>
<valueCodeableConcept>
<text
value="Treated as non-mutagenic due to lack of alerting structure"/>
</valueCodeableConcept>
</property>
<molecularWeight>
<amount>
<value value="459.58"/>
<unit value="g/mole"/>
<system value="http://unitsofmeasure.org"/>
<code value="g/mol"/>
</amount>
</molecularWeight>
<structure>
<representation>
<document>
<!-- DocumentReference/impurity2doc -->
<reference
value="DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad9"/>
</document>
</representation>
</structure>
<name>
<name value="Impurity 2"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:13d68d1c-162c-8b6e-80f9-647b0ea97ad9"/>
<resource>
<DocumentReference>
<!-- impurity2doc -->
<id value="13d68d1c-162c-8b6e-80f9-647b0ea97ad9"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: DocumentReference</b><a name="13d68d1c-162c-8b6e-80f9-647b0ea97ad9"> </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 DocumentReference "13d68d1c-162c-8b6e-80f9-647b0ea97ad9" </p></div><p><b>status</b>: current</p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Data</b></td></tr><tr><td style="display: none">*</td><td>image/x-png</td><td>(base64 data - 7149 bytes)</td></tr></table></blockquote></div>
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<status value="current"/>
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="03d68d1c-162c-8b6e-80f9-647b0ea97ad3"> </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 "03d68d1c-162c-8b6e-80f9-647b0ea97ad3" </p></div><blockquote><p><b>characterization</b></p><p><b>technique</b>: Organic impurities by HPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>characterization</b></p><p><b>technique</b>: Chromatographic retention <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Rule-based (Q)Sar <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#1233444)</span></p><p><b>value</b>: Negative <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicity-local-pq.html">CodeSystem - Mutagenicity</a>#negative)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Statistical (Q)Sar <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#123555)</span></p><p><b>value</b>: Negative <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicity-local-pq.html">CodeSystem - Mutagenicity</a>#negative)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: ICH M7 Classification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#123556)</span></p><p><b>value</b>: Class 5 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-ich-m7-classification-local-pq.html">CodeSystem - ICH M7 Classification</a>#class-5)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Mutagenicity Comment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#123557)</span></p><p><b>value</b>: Treated as non-mutagenic due to lack of alerting structure <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><h3>MolecularWeights</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Amount</b></td></tr><tr><td style="display: none">*</td><td>144.173 g/mole<span style="background: LightGoldenRodYellow"> (Details: UCUM code g/mol = 'g/mol')</span></td></tr></table><blockquote><p><b>structure</b></p><blockquote><p><b>representation</b></p><p><b>document</b>: <a href="#DocumentReference_13d68d1c-162c-8b6e-80f9-647b0ea97ad3">See above (DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad3)</a></p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: SMILES <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-substance-representation-format.html">Substance Representation Format</a>#SMILES)</span></p><p><b>representation</b>: OC1=CC2=C(C=C1)C=CC=C2</p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: InChI <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-substance-representation-format.html">Substance Representation Format</a>#InChI)</span></p><p><b>representation</b>: 1S/C10H8O/c11-10-6-5-8-3-1-2-4-9(8)7-10/h1-7,11H</p></blockquote></blockquote><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>2-Naphthol <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-CAS.html">Chemical abstract codes</a>#135-19-3)</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>β-naphthol</td></tr></table></div>
</text>
<characterization>
<technique>
<text value="Organic impurities by HPLC"/>
</technique>
</characterization>
<characterization>
<technique>
<text value="Chromatographic retention"/>
</technique>
</characterization>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="1233444"/>
<display value="Rule-based (Q)Sar"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicity-local-pq"/>
<code value="negative"/>
<display value="Negative"/>
</coding>
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<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="123555"/>
<display value="Statistical (Q)Sar"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicity-local-pq"/>
<code value="negative"/>
<display value="Negative"/>
</coding>
</valueCodeableConcept>
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<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="123556"/>
<display value="ICH M7 Classification"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-ich-m7-classification-local-pq"/>
<code value="class-5"/>
<display value="Class 5"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="123557"/>
<display value="Mutagenicity Comment"/>
</coding>
</type>
<valueCodeableConcept>
<text
value="Treated as non-mutagenic due to lack of alerting structure"/>
</valueCodeableConcept>
</property>
<molecularWeight>
<amount>
<value value="144.173"/>
<unit value="g/mole"/>
<system value="http://unitsofmeasure.org"/>
<code value="g/mol"/>
</amount>
</molecularWeight>
<structure>
<representation>
<document>
<!-- DocumentReference/impurityNaptholDoc -->
<reference
value="DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad3"/>
</document>
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<representation>
<type>
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<system
value="http://hl7.org/fhir/substance-representation-format"/>
<code value="SMILES"/>
<display value="SMILES"/>
</coding>
</type>
<representation value="OC1=CC2=C(C=C1)C=CC=C2"/>
</representation>
<representation>
<type>
<coding>
<system
value="http://hl7.org/fhir/substance-representation-format"/>
<code value="InChI"/>
<display value="InChI"/>
</coding>
</type>
<representation
value="1S/C10H8O/c11-10-6-5-8-3-1-2-4-9(8)7-10/h1-7,11H"/>
</representation>
</structure>
<code>
<code>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/CAS"/>
<code value="135-19-3"/>
<display value="2-Naphthol"/>
</coding>
</code>
</code>
<name>
<name value="β-naphthol"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:13d68d1c-162c-8b6e-80f9-647b0ea97ad3"/>
<resource>
<DocumentReference>
<!-- impurityNaptholDoc -->
<id value="13d68d1c-162c-8b6e-80f9-647b0ea97ad3"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: DocumentReference</b><a name="13d68d1c-162c-8b6e-80f9-647b0ea97ad3"> </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 DocumentReference "13d68d1c-162c-8b6e-80f9-647b0ea97ad3" </p></div><p><b>status</b>: current</p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Data</b></td></tr><tr><td style="display: none">*</td><td>image/x-png</td><td>(base64 data - 4093 bytes)</td></tr></table></blockquote></div>
</text>
<status value="current"/>
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<!-- impurityPropanol -->
<id value="03d68d1c-162c-8b6e-80f9-647b0ea97ad4"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="03d68d1c-162c-8b6e-80f9-647b0ea97ad4"> </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 "03d68d1c-162c-8b6e-80f9-647b0ea97ad4" </p></div><blockquote><p><b>characterization</b></p><p><b>technique</b>: Impurity content by LC-MS <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>characterization</b></p><p><b>technique</b>: UV spectroscopy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>characterization</b></p><p><b>technique</b>: NMR spectroscopy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Rule-based (Q)Sar <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#1233444)</span></p><p><b>value</b>: Positive <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicity-local-pq.html">CodeSystem - Mutagenicity</a>#positive)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Statistical (Q)Sar <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#123555)</span></p><p><b>value</b>: Positive <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicity-local-pq.html">CodeSystem - Mutagenicity</a>#positive)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: ICH M7 Classification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#123556)</span></p><p><b>value</b>: Class 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-ich-m7-classification-local-pq.html">CodeSystem - ICH M7 Classification</a>#class-2)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Mutagenicity Comment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-mutagenicityClassificationType-local-pq.html">CodeSystem - Mutagenicity Classification Type</a>#123557)</span></p><p><b>value</b>: Control at or below qualification threshold <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><h3>MolecularWeights</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Amount</b></td></tr><tr><td style="display: none">*</td><td>245.32 g/mole<span style="background: LightGoldenRodYellow"> (Details: UCUM code g/mol = 'g/mol')</span></td></tr></table><blockquote><p><b>structure</b></p><h3>Representations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Document</b></td></tr><tr><td style="display: none">*</td><td><a href="#DocumentReference_13d68d1c-162c-8b6e-80f9-647b0ea97ad4">See above (DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad4)</a></td></tr></table></blockquote><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>1-(Ethylamino)-3-(2-naphthyloxy)-2-propanol</td></tr></table></div>
</text>
<characterization>
<technique>
<text value="Impurity content by LC-MS"/>
</technique>
</characterization>
<characterization>
<technique>
<text value="UV spectroscopy"/>
</technique>
</characterization>
<characterization>
<technique>
<text value="NMR spectroscopy"/>
</technique>
</characterization>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="1233444"/>
<display value="Rule-based (Q)Sar"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicity-local-pq"/>
<code value="positive"/>
<display value="Positive"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="123555"/>
<display value="Statistical (Q)Sar"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicity-local-pq"/>
<code value="positive"/>
<display value="Positive"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="123556"/>
<display value="ICH M7 Classification"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-ich-m7-classification-local-pq"/>
<code value="class-2"/>
<display value="Class 2"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-mutagenicityClassificationType-local-pq"/>
<code value="123557"/>
<display value="Mutagenicity Comment"/>
</coding>
</type>
<valueCodeableConcept>
<text value="Control at or below qualification threshold"/>
</valueCodeableConcept>
</property>
<molecularWeight>
<amount>
<value value="245.32"/>
<unit value="g/mole"/>
<system value="http://unitsofmeasure.org"/>
<code value="g/mol"/>
</amount>
</molecularWeight>
<structure>
<representation>
<document>
<!-- DocumentReference/impurityPropanolDoc -->
<reference
value="DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad4"/>
</document>
</representation>
</structure>
<!-- not in CAS -->
<name>
<name value="1-(Ethylamino)-3-(2-naphthyloxy)-2-propanol"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:13d68d1c-162c-8b6e-80f9-647b0ea97ad4"/>
<resource>
<DocumentReference>
<!-- impurityPropanolDoc -->
<id value="13d68d1c-162c-8b6e-80f9-647b0ea97ad4"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: DocumentReference</b><a name="13d68d1c-162c-8b6e-80f9-647b0ea97ad4"> </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 DocumentReference "13d68d1c-162c-8b6e-80f9-647b0ea97ad4" </p></div><p><b>status</b>: current</p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Data</b></td></tr><tr><td style="display: none">*</td><td>image/x-png</td><td>(base64 data - 5119 bytes)</td></tr></table></blockquote></div>
</text>
<status value="current"/>
<content>
<attachment>
<contentType value="image/x-png"/>
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<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"><p><b>Generated Narrative: Organization</b><a name="062bf235-44e2-55c4-9213-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 "062bf235-44e2-55c4-9213-bbe5e12d5620" </p></div><p><b>identifier</b>: id: 3003040516</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>
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<!-- FDA establishment identifier -->
<system value="urn:oid:2.16.840.1.113883.4.82"/>
<value value="3003040516"/>
</identifier>
<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>
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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