Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon 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 1.1.6 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: 8202d18a-df68-4cbd-912d-59c7cff5cfa6

Generated Narrative: SubstanceDefinition 8202d18a-df68-4cbd-912d-59c7cff5cfa6

identifier: ironImpurity

classification: Elemental Impurities

structure

technique: UV Spectroscopy

Representations

-TypeRepresentation
*Structure[Fe]

Codes

-Code
*E1UOL152H7

Names

-NameTypePreferred
*IRONGSRS Preferred Termtrue