specified degradation product
- Guideline or reference source
- ICHQ3B Impurities in new drug products
- Definition
- A degradation product that is individually listed and limited with a specific acceptance criterion in the new drug product specification. A specified degradation product can be either identified or unidentified.
- Broader Term
- degradation product, impurity
- Related Term
- identified degradation product
- unidentified degradation product
- unspecified degradation product
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