unidentified degradation product
- Guideline or reference source
- ICHQ3B Impurities in new drug products
- Definition
- A degradation product for which a structural characterisation has not been achieved and that is defined solely by qualitative analytical properties (e.g., chromatographic retention time).
- Broader Term
- degradation product, impurity
- Related Term
- identified degradation product
- specified degradation product
- unspecified degradation product
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