Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
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<id value="58ae52aa-c81e-415a-8791-e67a3195290d"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"/>
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<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition </b><a name="58ae52aa-c81e-415a-8791-e67a3195290d"> </a><a name="hc58ae52aa-c81e-415a-8791-e67a3195290d"> </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">ResourceSubstanceDefinition "58ae52aa-c81e-415a-8791-e67a3195290d" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-drug-product-substance-impurity.html">Drug Substance Impurity</a></p></div><p><b>identifier</b>: DCM</p><p><b>classification</b>: Residual Solvent <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C176815)</span></p><blockquote><p><b>structure</b></p><p><b>technique</b>: Leftover Solvent <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>representation</b></p><p><b>type</b>: InChI File (small molecule) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C54683)</span></p><p><b>representation</b>: YMWUJEATGCHHMB-UHFFFAOYSA-N</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="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C54684)</span></p><p><b>representation</b>: ClCCl</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>588X2YUY0A <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html">Unique Ingredient Identifier (UNII)</a>#588X2YUY0A)</span></td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style="display: none">*</td><td>DICHLOROMETHANE</td><td>Generic Name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C97054)</span></td><td>true</td></tr></table></div>
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<value value="DCM"/>
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value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C176815"/>
<display value="Residual Solvent"/>
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</classification>
<structure>
<technique>
<text value="Leftover Solvent"/>
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<representation>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C54683"/>
<display value="InChI File (small molecule)"/>
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<representation value="YMWUJEATGCHHMB-UHFFFAOYSA-N"/>
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<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C54684"/>
<display value="SMILES"/>
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<representation value="ClCCl"/>
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<code>
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<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="588X2YUY0A"/>
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<name>
<name value="DICHLOROMETHANE"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C97054"/>
<display value="Generic Name"/>
</coding>
</type>
<preferred value="true"/>
</name>
</SubstanceDefinition>