Assay at low ppm level of dimethyl sulfate in starting materials for API synthesis using derivatization in ionic liquid media and LC–MS

Author:

Grinberg Nelu,Albu Florin,Fandrick Keith,Iorgulescu Elena,Medvedovici Andrei

Publisher

Elsevier BV

Subject

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

Reference23 articles.

1. Comparative potencies of induction of point mutations and genetic duplications by the methylating agents methylazoxymethanol and dimethyl sulfate in bacteria;Hoffmann;Mutagenesis,2002

2. Genotoxicity profiles of common alkyl halides and esters with alkylating activity;Sobol;Mutat. Res.,2007

3. Recent developments in the risk assessment of potentially genotoxic impurities in pharmaceutical drug substances;Humfrey;Toxicol. Sci.,2007

4. Approaches to assessment, testing decisions, and analytical determination of genotoxic impurities in drug substances;Pierson;Org. Process Res. Dev.,2009

5. Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMEA), Guideline on the Limits of Genotoxic Impurities, London, UK, June 2006 (EMEA/CHMP/QWP/251344/2006).

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