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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:
CPMP/ICH/2738/99
Origin/Publisher:
EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Document Type:
Note for Guidance
Content:
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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