Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ and changes regularly. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
<id value="30536c0e-456c-4f90-9f02-da7be1d289e9"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s10"/>
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<identifier>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-ig-version">
<valueString value="0.1.20"/>
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<system value="urn:ietf:rfc:3986"/>
<value value="urn:uuid:1bf43677-1c61-41dd-93c2-8ec7f327d0f1"/>
</identifier>
<type value="document"/>
<timestamp value="2023-12-15T22:19:47.022Z"/>
<entry>
<fullUrl value="urn:uuid:260f5aa3-23d2-4999-8e5f-70f247390ee5"/>
<resource>
<Composition>
<id value="260f5aa3-23d2-4999-8e5f-70f247390ee5"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s10"/>
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_260f5aa3-23d2-4999-8e5f-70f247390ee5"> </a><p><b>Generated Narrative: Composition</b><a name="260f5aa3-23d2-4999-8e5f-70f247390ee5"> </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 Composition "260f5aa3-23d2-4999-8e5f-70f247390ee5" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ectd-composition-32s10.html">eCTD Substance General Information</a></p></div><p><b>identifier</b>: Substance General - levoThyroxine</p><p><b>status</b>: final</p><p><b>type</b>: Substance General Information <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-comp-section-types.html">Code System PQCMC Comp Section Types</a>#32S10)</span></p><p><b>date</b>: 2023-12-15 22:19:47+0000</p><p><b>author</b>: <a href="#Organization_b69435a0-45c6-4d44-9fde-b354e17408d7">See above (urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7)</a></p><p><b>title</b>: eCTD Substance General Information for levoThyroxine</p></div>
</text>
<identifier>
<value value="Substance General - levoThyroxine"/>
</identifier>
<status value="final"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"/>
<code value="32S10"/>
<display value="Substance General Information"/>
</coding>
</type>
<date value="2023-12-15T22:19:47.022Z"/>
<author>
<reference value="urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7"/>
</author>
<title value="eCTD Substance General Information for levoThyroxine"/>
<section>
<title
value="Drug Substance Nomeclature and Structure for levoThyroxine"/>
<entry>
<reference value="urn:uuid:21b6b724-507e-4cf4-a462-93334b98d166"/>
</entry>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:21b6b724-507e-4cf4-a462-93334b98d166"/>
<resource>
<SubstanceDefinition>
<id value="21b6b724-507e-4cf4-a462-93334b98d166"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_21b6b724-507e-4cf4-a462-93334b98d166"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="21b6b724-507e-4cf4-a462-93334b98d166"> </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 "21b6b724-507e-4cf4-a462-93334b98d166" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-drug-substance-nomenclature-structure.html">Substance General Information</a></p></div><p><b>identifier</b>: levoThyroxine</p><p><b>classification</b>: Chemical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ema-dummy.html">Dummy EMA Codesystem</a>#1)</span></p><p><b>manufacturer</b>: <a href="#Organization_e875ef93-a730-4c44-bead-53663ae7f501">See above (urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501)</a></p><p><b>supplier</b>: <a href="#Organization_e165f057-5eed-4e64-8328-4438fc88fb1b">See above (urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b)</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 u<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C41127 = 'u')</span></td></tr></table><blockquote><p><b>structure</b></p><p><b>technique</b>: NMR Spectroscopy <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">Dummy NCIT Codesystem</a>#C54683)</span></p><p><b>representation</b>: YDTFRJLNMPSCFM-YDALLXLXSA-M</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">Dummy NCIT Codesystem</a>#C54684)</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></blockquote><blockquote><p><b>representation</b></p><p><b>document</b>: <a href="#DocumentReference_d94ad7ac-b935-432f-bc68-312b6b8dcca7">See above (urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7)</a></p></blockquote><blockquote><p><b>representation</b></p><p><b>document</b>: <a href="#DocumentReference_22bd989e-8056-494f-9bc1-195d13428179">See above (urn:uuid:22bd989e-8056-494f-9bc1-195d13428179)</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>054I36CPMN <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (gsrs.ncats.nih.gov#054I36CPMN)</span></td></tr></table><blockquote><p><b>name</b></p><p><b>name</b>: LEVOTHYROXINE SODIUM ANHYDROUS</p><p><b>type</b>: GSRS Preferred Term <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C203355)</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>: IUPAC Name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C203356)</span></p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: 55-03-8</p><p><b>type</b>: CAS Number <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C54682)</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="#SubstanceDefinition_832f22b4-6f0c-41f8-9b7d-f26f55e9973c">See above (urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973c)</a></td><td>Polymorph <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></div>
</text>
<identifier>
<value value="levoThyroxine"/>
</identifier>
<classification>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ema-dummy"/>
<code value="1"/>
<display value="Chemical"/>
</coding>
</classification>
<manufacturer>
<reference value="urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501"/>
</manufacturer>
<supplier>
<reference value="urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b"/>
</supplier>
<molecularWeight>
<amount>
<value value="798.85"/>
<unit value="u"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C41127"/>
</amount>
</molecularWeight>
<structure>
<technique>
<text value="NMR Spectroscopy"/>
</technique>
<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)"/>
</coding>
</type>
<representation value="YDTFRJLNMPSCFM-YDALLXLXSA-M"/>
</representation>
<representation>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C54684"/>
<display value="SMILES"/>
</coding>
</type>
<representation
value="[Na+].N[C@@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O"/>
</representation>
<representation>
<document>
<reference
value="urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7"/>
</document>
</representation>
<representation>
<document>
<reference
value="urn:uuid:22bd989e-8056-494f-9bc1-195d13428179"/>
</document>
</representation>
</structure>
<code>
<code>
<coding>
<system value="https://gsrs.ncats.nih.gov"/>
<code value="054I36CPMN"/>
</coding>
</code>
</code>
<name>
<name value="LEVOTHYROXINE SODIUM ANHYDROUS"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
<name>
<name
value="sodium;(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C203356"/>
<display value="IUPAC Name"/>
</coding>
</type>
</name>
<name>
<name value="55-03-8"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C54682"/>
<display value="CAS Number"/>
</coding>
</type>
</name>
<relationship>
<substanceDefinitionReference>
<reference value="urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973c"/>
</substanceDefinitionReference>
<type>
<text value="Polymorph"/>
</type>
</relationship>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973c"/>
<resource>
<SubstanceDefinition>
<id value="832f22b4-6f0c-41f8-9b7d-f26f55e9973c"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_832f22b4-6f0c-41f8-9b7d-f26f55e9973c"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="832f22b4-6f0c-41f8-9b7d-f26f55e9973c"> </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 "832f22b4-6f0c-41f8-9b7d-f26f55e9973c" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-polymorphic-form.html">Polymorphic Form</a></p></div><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>: InChI File (small molecule) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C54683)</span></p><p><b>representation</b>: ANMYAHDLKVNJJO-CURYUGHLSA-M</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">Dummy NCIT Codesystem</a>#C54684)</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></blockquote><blockquote><p><b>representation</b></p><p><b>document</b>: <a href="#DocumentReference_0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3">See above (urn:uuid:0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3)</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>0H00N2AHSP <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (gsrs.ncats.nih.gov#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>GSRS Preferred Term <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C203355)</span></td><td>true</td></tr></table></div>
</text>
<identifier>
<value value="DextroThyroxine"/>
</identifier>
<structure>
<molecularFormula value="C15H10I4NO4.Na.H2O"/>
<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)"/>
</coding>
</type>
<representation value="ANMYAHDLKVNJJO-CURYUGHLSA-M"/>
</representation>
<representation>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C54684"/>
<display value="SMILES"/>
</coding>
</type>
<representation
value="O.[Na+].N[C@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O"/>
</representation>
<representation>
<document>
<reference
value="urn:uuid:0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3"/>
</document>
</representation>
</structure>
<code>
<code>
<coding>
<system value="https://gsrs.ncats.nih.gov"/>
<code value="0H00N2AHSP"/>
</coding>
</code>
</code>
<name>
<name value="DEXTROTHYROXINE SODIUM"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7"/>
<resource>
<Organization>
<id value="b69435a0-45c6-4d44-9fde-b354e17408d7"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-organization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_b69435a0-45c6-4d44-9fde-b354e17408d7"> </a><p><b>Generated Narrative: Organization</b><a name="b69435a0-45c6-4d44-9fde-b354e17408d7"> </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 "b69435a0-45c6-4d44-9fde-b354e17408d7" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-cmc-sponsor-organization.html">Sponsor Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Large Life</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>123 Broad Way, New York, NY, United States</td></tr></table></div>
</text>
<identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134003"/>
<display value="DUNS"/>
</coding>
</type>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="143265222"/>
</identifier>
<name value="Large Life"/>
<contact>
<address>
<text value="123 Broad Way, New York, NY, United States"/>
<line value="123 Broad Way"/>
<city value="New York"/>
<state value="NY"/>
<postalCode value="100020"/>
<country value="United States"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b"/>
<resource>
<Organization>
<id value="e165f057-5eed-4e64-8328-4438fc88fb1b"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/supplier-organization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_e165f057-5eed-4e64-8328-4438fc88fb1b"> </a><p><b>Generated Narrative: Organization</b><a name="e165f057-5eed-4e64-8328-4438fc88fb1b"> </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 "e165f057-5eed-4e64-8328-4438fc88fb1b" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-supplier-organization.html">Supplier Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Vandechemie</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>Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium</td></tr></table></div>
</text>
<identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134003"/>
<display value="DUNS"/>
</coding>
</type>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="143265222"/>
</identifier>
<name value="Vandechemie"/>
<contact>
<address>
<text
value="Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium"/>
<line value="Ruzettelaan 39234"/>
<city value="Blankenberge"/>
<postalCode value="8370"/>
<country value="Belgium"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501"/>
<resource>
<Organization>
<id value="e875ef93-a730-4c44-bead-53663ae7f501"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization"/>
</meta>
<text>
<status value="generated"/>
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IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#0.1.20 based on FHIR 5.0.0. Generated 2024-03-04
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