Eudralex Volume 3 ICH Topic Q 3 B (R2) Impurities in New Drug Products
Title:
Eudralex Volume 3 ICH Topic Q 3 B (R2)
Impurities in New Drug Products
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.