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Eudralex Volume 3 Note for Guidance on Impurities Testing: Impurities in New Drug Substances (ICH Q3A (R2)) (CPMP/ICH/2737/99)

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

Document Type:
Note for Guidance
This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state.

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