Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.2 - 1.1.2 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 1.1.2 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: ffa30c0b-8031-436a-87f1-635b3bbe5989

Generated Narrative: SubstanceDefinition

ResourceSubstanceDefinition "ffa30c0b-8031-436a-87f1-635b3bbe5989"

Profile: Drug Substance Impurity

identifier: hydroxyApatite

classification: Degradation Product (PQ-CMC-FDA Temporary Codes#C176816)

structure

technique: formed from dicalcium phosphate degradation ()

representation

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

representation: XZFUZCHOJLQYHV-UHFFFAOYSA-M

representation

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

representation: [OH-].[Ca++].[Ca++].[Ca++].[Ca++].[Ca++].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O

Codes

-Code
*91D9GV0Z28 (Unique Ingredient Identifier (UNII)#91D9GV0Z28)

Names

-NameTypePreferred
*TRIBASIC CALCIUM PHOSPHATEGSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)true