Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.2 - 1.1.2
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.2 - 1.1.2
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 "55f2bbea-1a2d-4240-aef0-bc1a76b39212"
Profile: Drug Substance Impurity
identifier: DIOXANE
classification: Residual Solvent (PQ-CMC-FDA Temporary Codes#C176815)
| Technique |
| Residual Solvent () |
| Code |
| J8A3S10O7S (Unique Ingredient Identifier (UNII)#J8A3S10O7S) |
| Name | Type | Preferred |
| DIOXANE | Generic Name (PQ-CMC-FDA Temporary Codes#C97054) | true |
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.1.2 based on FHIR 5.0.0. Generated 2024-06-24
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