Investigation into the Formation of the Genotoxic Impurity Ethyl Besylate in the Final Step Manufacturing Process of UK-369,003-26, a Novel PDE5 Inhibitor

Author:

Hajikarimian Yousef1,Yeo Steve1,Ryan Robert W.1,Levett Philip1,Stoneley Christopher1,Singh Paul1

Affiliation:

1. Pfizer Global Research and Development, Chemical Research and Development, and Analytical Research and Development, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Reference17 articles.

1. Mesylate Ester Type Impurities Contained in Medicinal Products;Swissmedic Department for Control of the Medicinal Products Market, 23rd October 2007.

2. Hoog, T. J.d.Request to Assess the Risk of Occurrence of Contamination With Mesilate Esters and Other Related Compounds in Pharmaceuticals;Coordination Group for Mutual Recognition-Human Committee (CMDh), EMEA/CMDh/98694/2008:London, 27 February, 2008.

3. The Utility of Sulfonate Salts in Drug Development

4. Structure–activity considerations and in vitro approaches to assess the genotoxicity of 19 methane-, benzene- and toluenesulfonic acid esters

5. Salt formation to improve drug solubility

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