ICH Q3B (R2) Impurities in new drug products - Scientific guideline

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

Adopted Reference Number: CPMP/ICH/2738/99 Legal effective date: 01/08/2003