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

This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Example SubstanceDefinition: Polymorphic Form Example

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "832f22b4-6f0c-41f8-9b7d-f26f55e9973c"

Profile: Polymorphic Form

identifier: DextroThyroxine

structure

molecularFormula: C15H10I4NO4.Na.H2O

representation

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

representation: ANMYAHDLKVNJJO-CURYUGHLSA-M

representation

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

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

document: urn:uuid:0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3

Codes

-Code
*0H00N2AHSP (Unique Ingredient Identifier (UNII)#0H00N2AHSP)

Names

-NameTypePreferred
*DEXTROTHYROXINE SODIUMGSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)true