ICH Q3A (R2) Impurities in new drug substances

Current effective version

PDF iconAdopted guideline

Reference number CPMP/ICH/2737/99
Published 21/10/2006
Effective from 01/08/2002
Keywords Drug substance, impurities, organic, inorganic, solvents, reporting, control, qualification, specifications
Description This 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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