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="SubstanceDefinition_21b6b724-507e-4cf4-a462-93334b98d166"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition 21b6b724-507e-4cf4-a462-93334b98d166</b></p><a name="21b6b724-507e-4cf4-a462-93334b98d166"> </a><a name="hc21b6b724-507e-4cf4-a462-93334b98d166"> </a><a name="21b6b724-507e-4cf4-a462-93334b98d166-en-US"> </a><p><b>identifier</b>: levoThyroxine</p><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>manufacturer</b>: <a href="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-e875ef93-a730-4c44-bead-53663ae7f501">Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000</a></p><p><b>supplier</b>: <a href="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-e165f057-5eed-4e64-8328-4438fc88fb1b">Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000</a></p><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>798.85 unified atomic mass unit<span style="background: LightGoldenRodYellow"> (Details: UCUM codeu = 'u')</span></td></tr></table><blockquote><p><b>structure</b></p><p><b>technique</b>: <span title="Codes:">NMR Spectroscopy</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>: YDTFRJLNMPSCFM-YDALLXLXSA-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>: [Na+].N[C@@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([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><p><b>representation</b></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54273}">Picture</span></p><p><b>document</b>: <a href="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-d94ad7ac-b935-432f-bc68-312b6b8dcca7">Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000</a></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 C103240}">CHEMICAL STRUCTURE</span></p><p><b>document</b>: <a href="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-22bd989e-8056-494f-9bc1-195d13428179">Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000</a></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 054I36CPMN}">054I36CPMN</span></td></tr></table><blockquote><p><b>name</b></p><p><b>name</b>: LEVOTHYROXINE SODIUM ANHYDROUS</p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></p><p><b>preferred</b>: true</p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: sodium;(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate</p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203356}">IUPAC Name</span></p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: 55-03-8</p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54682}">CAS Number</span></p></blockquote><h3>Relationships</h3><table class="grid"><tr><td style="display: none">-</td><td><b>SubstanceDefinition[x]</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-832f22b4-6f0c-41f8-9b7d-f26f55e9973c">Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000</a></td><td><span title="Codes:">Polymorph</span></td></tr></table></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_832f22b4-6f0c-41f8-9b7d-f26f55e9973c"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition 832f22b4-6f0c-41f8-9b7d-f26f55e9973c</b></p><a name="832f22b4-6f0c-41f8-9b7d-f26f55e9973c"> </a><a name="hc832f22b4-6f0c-41f8-9b7d-f26f55e9973c"> </a><a name="832f22b4-6f0c-41f8-9b7d-f26f55e9973c-en-US"> </a><p><b>identifier</b>: DextroThyroxine</p><blockquote><p><b>structure</b></p><p><b>molecularFormula</b>: C15H10I4NO4.Na.H2O</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>: ANMYAHDLKVNJJO-CURYUGHLSA-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>: O.[Na+].N[C@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([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><p><b>representation</b></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C54273}">Picture</span></p><p><b>document</b>: <a href="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3">Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000</a></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 0H00N2AHSP}">0H00N2AHSP</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>DEXTROTHYROXINE SODIUM</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>
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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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