Example SubstanceDefinition for Carrageenan - Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA v1.0.0-ballot

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

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: 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

Name

Type

Preferred

Carrageenan

GSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)

true

SourceMaterials

Type

Genus

Species

CountryOfOrigin

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)