Genotoxic Impurities In Pharmaceuticals
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Risk Assessment and Management of Genotoxic Impurities …
www.nihs.go.jpGenotoxic Impurities in Pharmaceuticals Masamitsu Honma, Ph.D. Division of Genetics and Mutagenesis, National Institute of Health Sciences, Tokyo, JAPAN. Base + toluene Pd catalyst/ Ligand 1) conc H 2SO4 LiOt-Bu THF 1) NaBH4 / MgCl2 /MeOH F3C X CN NH2 F 3 C N H CN F C N H O NH2 F3C N H O N H O O 2) aqHCl F 3 C N HN O O F 3 C N HN O O O O
This document was valid from 1 September 2008 to 1 June ...
www.ema.europa.euidentified as acceptable for genotoxic impurities in pharmaceuticals by the CHMP. 2. DEFINITION AND SCOPE . Metal catalysts and metal reagents are defined here as chemical substances that are used to change the rate of chemical reactions or which act on other chemical substances in chemical reactions. For the
Genotoxic Impurities in Pharmaceuticals - InTech
cdn.intechopen.com17 Genotoxic Impurities in Pharmaceuticals Abolghasem Jouyban 1 and Hamed Parsa 2 1Drug Applied Research Center and Faculty of Pharmacy, 2Tuberculosis and Lung Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran 1. Introduction Genotoxic compounds induce genetic mutation s and/or chromosomal rearrangements and