unspecified degradation product
- Guideline or reference source
- ICHQ3B Impurities in new drug products
- Definition
- A degradation product that is limited by a general acceptance criterion, but not individually listed with its own specific acceptance criterion, in the new drug product specification.
- Broader Term
- degradation product, impurity
- Related Term
- identified degradation product
- specified degradation product
- unidentified degradation product
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