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: Polymorphic Form Example

Generated Narrative: SubstanceDefinition 832f22b4-6f0c-41f8-9b7d-f26f55e9973c

identifier: DextroThyroxine

structure

molecularFormula: C15H10I4NO4.Na.H2O

representation

type: Structure

representation: ANMYAHDLKVNJJO-CURYUGHLSA-M

representation

type: Structure

representation: O.[Na+].N[C@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O

representation

type: Graphics

document: Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000

Codes

-Code
*0H00N2AHSP

Names

-NameTypePreferred
*DEXTROTHYROXINE SODIUMGSRS Preferred Termtrue