Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
{
"resourceType" : "SubstanceDefinition",
"id" : "21b6b724-507e-4cf4-a462-93334b98d166",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"21b6b724-507e-4cf4-a462-93334b98d166\"> </a><a name=\"hc21b6b724-507e-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-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></p><p><b>manufacturer</b>: <a href=\"Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-e875ef93-a730-4c44-bead-53663ae7f501\">urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501</a></p><p><b>supplier</b>: <a href=\"Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-e165f057-5eed-4e64-8328-4438fc88fb1b\">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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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=\"Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-d94ad7ac-b935-432f-bc68-312b6b8dcca7\">urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7</a></p></blockquote><blockquote><p><b>representation</b></p><p><b>document</b>: <a href=\"Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-22bd989e-8056-494f-9bc1-195d13428179\">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\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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\">PQ-CMC-FDA Temporary Codes</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=\"Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-832f22b4-6f0c-41f8-9b7d-f26f55e9973c\">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-ncit-dummy",
"code" : "C48807",
"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" : {
"reference" : "urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7"
}
},
{
"document" : {
"reference" : "urn:uuid:22bd989e-8056-494f-9bc1-195d13428179"
}
}
]
},
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "054I36CPMN"
}
]
}
}
],
"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"
}
}
]
}
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-08
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