Determination of genotoxic impurities monomethyl sulfate and dimethyl sulfate in active pharmaceutical ingredients-Reference-Cited by-同舟云学术

Determination of genotoxic impurities monomethyl sulfate and dimethyl sulfate in active pharmaceutical ingredients

Published:2017 Issue:7 Volume:9 Page:1112-1118
ISSN:1759-9660
Container-title:Analytical Methods
language:en
Short-container-title:Anal. Methods

Author:

Abdel Rahman Mona Hamdy¹²³⁴⁵,Gullick Darren R.⁵⁶⁷⁸⁹,Hoerner Joshua¹⁰⁸⁹,Bartlett Michael G.⁵⁶⁷⁸⁹^ORCID

Affiliation:

1. Department of Analytical Chemistry

2. Faculty of Pharmacy

3. Ain Shams University

4. Egypt

5. Department of Pharmaceutical and Biomedical Sciences

6. College of Pharmacy

7. University of Georgia

8. Athens

9. USA

10. Noramco

Abstract

Dimethyl sulfate (DMS) and monomethyl sulfate (MMS) are potential genotoxic impurities created during synthesis of some active pharmaceutical ingredients.

Publisher

Royal Society of Chemistry (RSC)

Subject

General Engineering,General Chemical Engineering,Analytical Chemistry

Link

http://pubs.rsc.org/en/content/articlepdf/2017/AY/C7AY00044H

Reference16 articles.

1. Genetic effects of dimethyl sulfate, diethyl sulfate, and related compounds

2. Genotoxicity profiles of common alkyl halides and esters with alkylating activity

3. Monoalkyl sulfates as alkylating agents in water, alkylsulfatase rate enhancements, and the "energy-rich" nature of sulfate half-esters

4. U.S. Department of Health and Human Services , F.D.A. and Center for Drug Evaluation and Research (CDER), Guidance for Industry – M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, Silver Spring, MD, USA, 2015

5. Recent Developments in the Risk Assessment of Potentially Genotoxic Impurities in Pharmaceutical Drug Substances

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