product-related impurities
- Guideline or reference source
- ICHQ6B Test procedures and acceptance criteria for biotechnological/biological products
- Definition
- Molecular variants of the desired product (e.g., precursors, certain degradation products arising during manufacture and/or storage) which do not have properties comparable to those of the desired product with respect to activity, efficacy, and safety.
- Broader Term
- impurity
- Related Term
- process-related impurities
- product-related substances
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