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ICH Topic Q 3 A Impurities Testing Guideline: …
www.pharma.gally.chCPMP/ICH/142/95 2/11 IMPURITIES IN NEW DRUG SUBSTANCES ICH Harmonised Tripartite Guideline [EMEA Status as of May 1995] 1. PREAMBLE This document is intended to provide guidance for registration applications on the content and
ICH Topic Q 1 A Stability Testing Guidelines: …
www.pharma.gally.chCPMP/ICH/380/95 2/13 DRUG SUBSTANCE General Information on the stability of the drug substance is an integral part of the systematic