Determination of low ppm levels of dimethyl sulfate in an aqueous soluble API intermediate using liquid–liquid extraction and GC–MS

Author:

Zheng Jie,Pritts Wayne A.,Zhang Shuhong,Wittenberger Steve

Publisher

Elsevier BV

Subject

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

Reference36 articles.

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

4. Chemical reagents as potential impurities of pharmaceutical products: investigations on their genotoxic activity;Friscia;J. Environ. Pathol. Toxicol. Oncol.,1994

5. Toxicological overview of impurities in pharmaceutical products;Jacobson-Kram;Adv. Drug Deliv. Rev.,2007

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