Determination of genotoxic epoxide at trace level in drug substance by direct injection GC/MS

Author:

Chen Liqin,Zhang Wei,Hu Steven

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference24 articles.

1. Carcinogenicity categorization of chemicals −new aspects to be considered in a European perspective;Bolt;Toxicol. Lett.,2004

2. Regulating impurities in pharmaceutical products: a tolerability of risk approach?;Bouder;Expert Rev. Clin. Pharmacol.,2008

3. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity;Müller;Regul. Toxicol. Pharmacol.,2006

4. Guideline on the Limits of Genotoxic Impurities CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006;EMEA-CHMP,2006

5. Guidance for Industry: Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches (draft);USFDA,2008

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