impurity profile
- Guideline or reference source
- ICHQ3A Impurities in new drug substances
- ICHQ3B Impurities in new drug products
- ICHQ7 Good manufacturing practice for active pharmaceutical ingredients
- Definition
- A description of the identified and unidentified impurities present in a new drug substance or drug product.
- Related Term
- identified impurity
- unidentified impurity
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