Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI United States of America flag

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

Example SubstanceDefinition: Drug Substance Nomenclature and Structure

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "21b6b724-507e-4cf4-a462-93334b98d166"

Profile: Substance General Information

identifier: levoThyroxine

classification: Chemical (Dummy EMA Codesystem#1)

manufacturer: urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501

supplier: urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b

MolecularWeights

-Amount
*798.85 u (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C41127 = 'u')

structure

technique: NMR Spectroscopy ()

representation

type: InChI File (small molecule) (Dummy NCIT Codesystem#C54683)

representation: YDTFRJLNMPSCFM-YDALLXLXSA-M

representation

type: SMILES (Dummy NCIT Codesystem#C54684)

representation: [Na+].N[C@@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O

representation

document: urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7

representation

document: urn:uuid:22bd989e-8056-494f-9bc1-195d13428179

Codes

-Code
*054I36CPMN (gsrs.ncats.nih.gov#054I36CPMN)

name

name: LEVOTHYROXINE SODIUM ANHYDROUS

type: GSRS Preferred Term (Dummy NCIT Codesystem#C203355)

preferred: true

name

name: sodium;(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate

type: IUPAC Name (Dummy NCIT Codesystem#C203356)

name

name: 55-03-8

type: CAS Number (Dummy NCIT Codesystem#C54682)

Relationships

-SubstanceDefinition[x]Type
*urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973cPolymorph ()