product-related substances
- Guideline or reference source
- ICHQ6B Test procedures and acceptance criteria for biotechnological/biological products
- Definition
- Molecular variants of the desired product formed during manufacture and/or storage which are active and have no deleterious effect on the safety and efficacy of the drug product. These variants possess properties comparable to the desired product and are not considered impurities.
- Related Term
- product-related impurities
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