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
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
Code |
91D9GV0Z28 (Unique Ingredient Identifier (UNII)#91D9GV0Z28) |
Name | Type | Preferred |
TRIBASIC CALCIUM PHOSPHATE | GSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355) | true |