ICH Q3B (R2) Impurities in new drug products

Current effective version

PDF iconAdopted guideline

Reference number CPMP/ICH/2738/99
Published 01/10/2006
Effective from 01/08/2003
Keywords Finished product, impurities, reporting, control, qualification, specifications
Description This 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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