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.

Keywords: Finished product, impurities, reporting, control, qualification, specifications

Current effective version

ICH: Q 3 B (R2): Impurities in new drug products - Step 5

AdoptedLegal effective date: Reference Number: CPMP/ICH/2738/99

English (EN) (150.84 KB - PDF)

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