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Eudralex Volume 3 Note for Guidance on Impurities in new Drug Products (ICH Q3B(R2))(CPMP/ICH/2738/99)

Short Title:

EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK

Document Type:
Note for Guidance
This document provides guidance for registration applications on the content and qualification of impurities in new drug products produced from chemically synthesised new drug substances not previously registered in a region or member state.

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