Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
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 2.0.0-ballot 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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<div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_8a07e353-9cf6-4f27-8a30-2c2d4f439847"> </a><p class="res-header-id"><b>Generated Narrative: Composition 8a07e353-9cf6-4f27-8a30-2c2d4f439847</b></p><a name="8a07e353-9cf6-4f27-8a30-2c2d4f439847"> </a><a name="hc8a07e353-9cf6-4f27-8a30-2c2d4f439847"> </a><a name="8a07e353-9cf6-4f27-8a30-2c2d4f439847-en-US"> </a><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use 32P55}">Product Characterisation of Impurities</span></p><p><b>date</b>: 2024-04-24 01:12:07+0000</p><p><b>author</b>: <a href="Bundle-9e8f2d16-66b1-47ec-878d-f50ae021985b.html#urn-uuid-98effc99-db2b-428d-89aa-0ce426e02788">Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000</a></p><p><b>title</b>: eCTD Product Characterisation of Impurities Composition for TabletCoatedBeadsCoatedAll</p></div>
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<title
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<section>
<title value="Impurities for TabletCoatedBeadsCoatedAll"/>
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<entry>
<fullUrl value="urn:uuid:ddd3abad-347c-4d2f-95f3-dd804e250502"/>
<resource>
<MedicinalProductDefinition>
<id value="ddd3abad-347c-4d2f-95f3-dd804e250502"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities"/>
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_ddd3abad-347c-4d2f-95f3-dd804e250502"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition ddd3abad-347c-4d2f-95f3-dd804e250502</b></p><a name="ddd3abad-347c-4d2f-95f3-dd804e250502"> </a><a name="hcddd3abad-347c-4d2f-95f3-dd804e250502"> </a><a name="ddd3abad-347c-4d2f-95f3-dd804e250502-en-US"> </a><p><b>identifier</b>: TabletCoatedBeadsCoatedAll</p><p><b>description</b>: </p><div><p>A drug product composed of one type of bead with two coatings inside a coated tablet</p>
</div><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42964}">TABLET, MULTILAYER</span></p><p><b>route</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38288}">ORAL</span></p><h3>Impurities</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-9e8f2d16-66b1-47ec-878d-f50ae021985b.html#urn-uuid-58ae52aa-c81e-415a-8791-e67a3195290d">Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000</a></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-9e8f2d16-66b1-47ec-878d-f50ae021985b.html#urn-uuid-ffa30c0b-8031-436a-87f1-635b3bbe5989">Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000</a></td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: LEVOTHYROXINE SODIUM ANHYDROUS 125mg</p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C96971}">Non-Proprietary</span></p><blockquote><p><b>part</b></p><p><b>part</b>: LEVOTHYROXINE SODIUM ANHYDROUS</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 125mg</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}">LEVOTHYROXINE SODIUM ANHYDROUS</span></p></blockquote></blockquote></div>
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<identifier>
<value value="TabletCoatedBeadsCoatedAll"/>
</identifier>
<description
value="A drug product composed of one type of bead with two coatings inside a coated tablet"/>
<combinedPharmaceuticalDoseForm>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C42964"/>
<display value="TABLET, MULTILAYER"/>
</coding>
</combinedPharmaceuticalDoseForm>
<route>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C38288"/>
<display value="ORAL"/>
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</route>
<impurity>
<reference>
<reference value="urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d"/>
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</impurity>
<impurity>
<reference>
<reference value="urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989"/>
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</impurity>
<name>
<productName value="LEVOTHYROXINE SODIUM ANHYDROUS 125mg"/>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96971"/>
<display value="Nonproprietary Name"/>
</coding>
<text value="Non-Proprietary"/>
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<part>
<part value="LEVOTHYROXINE SODIUM ANHYDROUS"/>
<type>
<coding>
<system
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<code value="SCI"/>
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<part>
<part value="125mg"/>
<type>
<coding>
<system
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<code value="STR"/>
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<text value="LEVOTHYROXINE SODIUM ANHYDROUS"/>
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<entry>
<fullUrl value="urn:uuid:98effc99-db2b-428d-89aa-0ce426e02788"/>
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<Organization>
<id value="98effc99-db2b-428d-89aa-0ce426e02788"/>
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<profile
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<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_98effc99-db2b-428d-89aa-0ce426e02788"> </a><p class="res-header-id"><b>Generated Narrative: Organization 98effc99-db2b-428d-89aa-0ce426e02788</b></p><a name="98effc99-db2b-428d-89aa-0ce426e02788"> </a><a name="hc98effc99-db2b-428d-89aa-0ce426e02788"> </a><a name="98effc99-db2b-428d-89aa-0ce426e02788-en-US"> </a><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: connectathon_Site</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>connectathon_Site, Restful Rd, Danbury, CT, USA</td></tr></table></div>
</text>
<identifier>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134003"/>
<display value="DUNS"/>
</coding>
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<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="143265222"/>
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<name value="connectathon_Site"/>
<contact>
<address>
<type value="postal"/>
<text value="connectathon_Site, Restful Rd, Danbury, CT, USA"/>
<line value="Restful Rd"/>
<city value="Danbury"/>
<state value="CT"/>
<postalCode value="06811"/>
<country value="USA"/>
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</Organization>
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</entry>
<entry>
<fullUrl value="urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d"/>
<resource>
<SubstanceDefinition>
<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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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_58ae52aa-c81e-415a-8791-e67a3195290d"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition 58ae52aa-c81e-415a-8791-e67a3195290d</b></p><a name="58ae52aa-c81e-415a-8791-e67a3195290d"> </a><a name="hc58ae52aa-c81e-415a-8791-e67a3195290d"> </a><a name="58ae52aa-c81e-415a-8791-e67a3195290d-en-US"> </a><p><b>identifier</b>: DCM</p><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176815}">Residual Solvent</span></p><blockquote><p><b>structure</b></p><p><b>technique</b>: <span title="Codes:">Leftover Solvent</span></p><blockquote><p><b>representation</b></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}">String</span></p><p><b>representation</b>: YMWUJEATGCHHMB-UHFFFAOYSA-N</p><p><b>format</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54683}">InChI File (small molecule)</span></p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}">String</span></p><p><b>representation</b>: ClCCl</p><p><b>format</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54684}">SMILES</span></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><span title="Codes:{http://fdasis.nlm.nih.gov 588X2YUY0A}">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><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C97054}">Generic Name</span></td><td>true</td></tr></table></div>
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<identifier>
<value value="DCM"/>
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<classification>
<coding>
<system
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<code value="C176815"/>
<display value="Residual Solvent"/>
</coding>
</classification>
<structure>
<technique>
<text value="Leftover Solvent"/>
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<representation>
<type>
<coding>
<system
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<code value="C45253"/>
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<representation value="YMWUJEATGCHHMB-UHFFFAOYSA-N"/>
<format>
<coding>
<system
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<code value="C54683"/>
<display value="InChI File (small molecule)"/>
</coding>
</format>
</representation>
<representation>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C45253"/>
</coding>
</type>
<representation value="ClCCl"/>
<format>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C54684"/>
<display value="SMILES"/>
</coding>
</format>
</representation>
</structure>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="588X2YUY0A"/>
</coding>
</code>
</code>
<name>
<name value="DICHLOROMETHANE"/>
<type>
<coding>
<system
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<code value="C97054"/>
<display value="Generic Name"/>
</coding>
</type>
<preferred value="true"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989"/>
<resource>
<SubstanceDefinition>
<id value="ffa30c0b-8031-436a-87f1-635b3bbe5989"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_ffa30c0b-8031-436a-87f1-635b3bbe5989"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition ffa30c0b-8031-436a-87f1-635b3bbe5989</b></p><a name="ffa30c0b-8031-436a-87f1-635b3bbe5989"> </a><a name="hcffa30c0b-8031-436a-87f1-635b3bbe5989"> </a><a name="ffa30c0b-8031-436a-87f1-635b3bbe5989-en-US"> </a><p><b>identifier</b>: hydroxyApatite</p><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176816}">Degradation Product</span></p><blockquote><p><b>structure</b></p><p><b>technique</b>: <span title="Codes:">formed from dicalcium phosphate degradation</span></p><blockquote><p><b>representation</b></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}">String</span></p><p><b>representation</b>: XZFUZCHOJLQYHV-UHFFFAOYSA-M</p><p><b>format</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54683}">InChI File (small molecule)</span></p></blockquote><blockquote><p><b>representation</b></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45253}">String</span></p><p><b>representation</b>: [OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O</p><p><b>format</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54684}">SMILES</span></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><span title="Codes:{http://fdasis.nlm.nih.gov 91D9GV0Z28}">91D9GV0Z28</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>TRIBASIC CALCIUM PHOSPHATE</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></td><td>true</td></tr></table></div>
</text>
<identifier>
<value value="hydroxyApatite"/>
</identifier>
<classification>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C176816"/>
<display value="Degradation Product"/>
</coding>
</classification>
<structure>
<technique>
<text value="formed from dicalcium phosphate degradation"/>
</technique>
<representation>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C45253"/>
</coding>
</type>
<representation value="XZFUZCHOJLQYHV-UHFFFAOYSA-M"/>
<format>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C54683"/>
<display value="InChI File (small molecule)"/>
</coding>
</format>
</representation>
<representation>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C45253"/>
</coding>
</type>
<representation
value="[OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O"/>
<format>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C54684"/>
<display value="SMILES"/>
</coding>
</format>
</representation>
</structure>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="91D9GV0Z28"/>
</coding>
</code>
</code>
<name>
<name value="TRIBASIC CALCIUM PHOSPHATE"/>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
</Bundle>
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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