Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot United States of America flag

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

Example SubstanceDefinition: Example SubstanceDefinition for anhydrous citric acid

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "fd84a8b5-9e96-451c-a5c6-097c943eb38a"

Profile: Excipient Drug Substance

identifier: Citric acid

classification: Chemical (PQ-CMC-FDA Temporary Codes#C48807)

grade: Company Standard (PQ-CMC-FDA Temporary Codes#C134009)

manufacturer: urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5

supplier: urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049

Codes

-Code
*XF417D3PSL (Unique Ingredient Identifier (UNII)#XF417D3PSL)

Names

-NameTypePreferred
*ANHYDROUS CITRIC ACIDGSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)true

SourceMaterials

-Type
*Chemical (PQ-CMC-FDA Temporary Codes#C48807)