Determination of trace levels of dimethyl sulfate in the presence of monomethyl sulfate by gas chromatography–mass spectrometry

Author:

Schäfer Claudia,Zöllner Peter

Publisher

Elsevier BV

Subject

Organic Chemistry,General Medicine,Biochemistry,Analytical Chemistry

Reference21 articles.

1. Approaches to Assessment, Testing Decisions, and Analytical Determination of Genotoxic Impurities in Drug Substances

2. Committee for Medicinal Products for Human Use (CHMP), Europen Medicines Agenca (EMEA), Guidline on the Limits of Genotoxic Impurities, London, UK (EMEA/CHMP/QWP/251344/2006), June 2006.

3. Guidance for Industry – Genotoxin and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches;U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER),2008

4. Recent advances in trace analysis of pharmaceutical genotoxic impurities

5. Ute Hübsch: dimethyl ether;Manfred Müller,2006

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