Ultra high performance liquid chromatography coupled with high resolution quantitation mass spectrometry method development and validation for determining genotoxic 2,5-dichlorobenzoyl chloride in MLN9708 drug substance

Author:

Fu Mingkun,Lu Qing,Hewitt Elizabeth,Wang Jun

Publisher

Elsevier BV

Subject

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

Reference23 articles.

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

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

3. Acceptability of low levels of genotoxic impurities in new drug substances: case reports;Leblanc;Int. J. Pharm. Med.,2004

4. Committee for Medicinal Products for Human Us (CHMP) Guideline on the limits of genotoxic impurities, CPMP/SWP/5199/02;European Medicines Agncy (EMA),2006

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

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