Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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 1.0.0-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

Example SubstanceDefinition: Polymorphic Form Example

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "832f22b4-6f0c-41f8-9b7d-f26f55e9973c"

Profile: Polymorphic Form

identifier: DextroThyroxine

structure

molecularFormula: C15H10I4NO4.Na.H2O

representation

type: InChI File (small molecule) (PQ-CMC-FDA Temporary Codes#C54683)

representation: ANMYAHDLKVNJJO-CURYUGHLSA-M

representation

type: SMILES (PQ-CMC-FDA Temporary Codes#C54684)

representation: O.[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:0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3

Codes

-Code
*0H00N2AHSP (Unique Ingredient Identifier (UNII)#0H00N2AHSP)

Names

-NameTypePreferred
*DEXTROTHYROXINE SODIUMGSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)true