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: 58ae52aa-c81e-415a-8791-e67a3195290d

Generated Narrative: SubstanceDefinition

ResourceSubstanceDefinition "58ae52aa-c81e-415a-8791-e67a3195290d"

Profile: Drug Substance Impurity

identifier: DCM

classification: Residual Solvent (PQ-CMC-FDA Temporary Codes#C176815)

structure

technique: Leftover Solvent ()

representation

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

representation: YMWUJEATGCHHMB-UHFFFAOYSA-N

representation

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

representation: ClCCl

Codes

-Code
*588X2YUY0A (Unique Ingredient Identifier (UNII)#588X2YUY0A)

Names

-NameTypePreferred
*DICHLOROMETHANEGeneric Name (PQ-CMC-FDA Temporary Codes#C97054)true