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 Carrageenan

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "0efb1188-04f0-44ba-bfe7-ca6169ca8703"

Profile: Excipient Drug Substance

identifier: carrageenan

classification: Structurally Diverse Substance (PQ-CMC-FDA Temporary Codes#C3641132)

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

manufacturer: urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579

Codes

-Code
*5C69YCD2YJ (Unique Ingredient Identifier (UNII)#5C69YCD2YJ)

Names

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

SourceMaterials

-TypeGenusSpeciesCountryOfOrigin
*Plant (PQ-CMC-FDA Temporary Codes#C14258)palmaria ()palmata ()United States of America (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#USA)