ICH Q3B (R2) Impurities in new drug products

Current effective version

PDF iconAdopted guideline

Reference numberCPMP/ICH/2738/99
Published01/10/2006
Effective from01/08/2003
KeywordsFinished product, impurities, reporting, control, qualification, specifications
DescriptionThis document provides guidance on the content and qualification of impurities in new drug products for registration applications. It applies to drug products produced from chemically synthesised new drug substances not previously registered in a region or Member State.


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