ICH Q3A (R2) Impurities in new drug substances

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Current effective version

Adopted guideline

Reference numberCPMP/ICH/2737/99
Published21/10/2006
Effective from01/08/2002
KeywordsDrug substance, impurities, organic, inorganic, solvents, reporting, control, qualification, specifications
DescriptionThis document provides guidance on the content and qualification of impurities in new drug substances for registration applications. It applies to drug substances produced by chemical syntheses and not previously registered in a region or Member State. It covers chemistry and safety aspects of impurities in new drug substances.


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