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
{
"resourceType" : "Bundle",
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"meta" : {
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🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s10"
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"type" : "document",
"timestamp" : "2023-12-15T22:19:47.022Z",
"entry" : [
{
"fullUrl" : "urn:uuid:260f5aa3-23d2-4999-8e5f-70f247390ee5",
"resource" : {
"resourceType" : "Composition",
"id" : "260f5aa3-23d2-4999-8e5f-70f247390ee5",
"meta" : {
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🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s10"
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"div" : "<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>"
},
"identifier" : [
{
"value" : "Substance General - levoThyroxine"
}
],
"status" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
"code" : "32S10",
"display" : "Substance General Information"
}
]
},
"date" : "2023-12-15T22:19:47.022Z",
"author" : [
{
"reference" : "urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7"
}
],
"title" : "eCTD Substance General Information for levoThyroxine",
"section" : [
{
"title" : "Drug Substance Nomeclature and Structure for levoThyroxine",
"entry" : [
{
"reference" : "urn:uuid:21b6b724-507e-4cf4-a462-93334b98d166"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:21b6b724-507e-4cf4-a462-93334b98d166",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "21b6b724-507e-4cf4-a462-93334b98d166",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure"
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"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : [
{
"value" : "levoThyroxine"
}
],
"classification" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ema-dummy",
"code" : "1",
"display" : "Chemical"
}
]
}
],
"manufacturer" : [
{
"reference" : "urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501"
}
],
"supplier" : [
{
"reference" : "urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b"
}
],
"molecularWeight" : [
{
"amount" : {
"value" : 798.85,
"unit" : "u",
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C41127"
}
}
],
"structure" : {
"technique" : [
{
"text" : "NMR Spectroscopy"
}
],
"representation" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C54683",
"display" : "InChI File (small molecule)"
}
]
},
"representation" : "YDTFRJLNMPSCFM-YDALLXLXSA-M"
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C54684",
"display" : "SMILES"
}
]
},
"representation" : "[Na+].N[C@@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O"
},
{
"document" : {
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{
"document" : {
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"code" : [
{
"code" : {
"coding" : [
{
"system" : "https://gsrs.ncats.nih.gov",
"code" : "054I36CPMN"
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}
],
"name" : [
{
"name" : "LEVOTHYROXINE SODIUM ANHYDROUS",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
},
{
"name" : "sodium;(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C203356",
"display" : "IUPAC Name"
}
]
}
},
{
"name" : "55-03-8",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C54682",
"display" : "CAS Number"
}
]
}
}
],
"relationship" : [
{
"substanceDefinitionReference" : {
"reference" : "urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973c"
},
"type" : {
"text" : "Polymorph"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973c",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "832f22b4-6f0c-41f8-9b7d-f26f55e9973c",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : [
{
"value" : "DextroThyroxine"
}
],
"structure" : {
"molecularFormula" : "C15H10I4NO4.Na.H2O",
"representation" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C54683",
"display" : "InChI File (small molecule)"
}
]
},
"representation" : "ANMYAHDLKVNJJO-CURYUGHLSA-M"
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C54684",
"display" : "SMILES"
}
]
},
"representation" : "O.[Na+].N[C@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O"
},
{
"document" : {
"reference" : "urn:uuid:0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3"
}
}
]
},
"code" : [
{
"code" : {
"coding" : [
{
"system" : "https://gsrs.ncats.nih.gov",
"code" : "0H00N2AHSP"
}
]
}
}
],
"name" : [
{
"name" : "DEXTROTHYROXINE SODIUM",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
]
}
},
{
"fullUrl" : "urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7",
"resource" : {
"resourceType" : "Organization",
"id" : "b69435a0-45c6-4d44-9fde-b354e17408d7",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-organization"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134003",
"display" : "DUNS"
}
]
},
"system" : "urn:oid:1.3.6.1.4.1.519.1",
"value" : "143265222"
}
],
"name" : "Large Life",
"contact" : [
{
"address" : {
"text" : "123 Broad Way, New York, NY, United States",
"line" : [
"123 Broad Way"
],
"city" : "New York",
"state" : "NY",
"postalCode" : "100020",
"country" : "United States"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b",
"resource" : {
"resourceType" : "Organization",
"id" : "e165f057-5eed-4e64-8328-4438fc88fb1b",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/supplier-organization"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"code" : "C134003",
"display" : "DUNS"
}
]
},
"system" : "urn:oid:1.3.6.1.4.1.519.1",
"value" : "143265222"
}
],
"name" : "Vandechemie",
"contact" : [
{
"address" : {
"text" : "Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium",
"line" : [
"Ruzettelaan 39234"
],
"city" : "Blankenberge",
"postalCode" : "8370",
"country" : "Belgium"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501",
"resource" : {
"resourceType" : "Organization",
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"meta" : {
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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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