PQRI Project Update. Fundamental Understanding of Sulfonate Ester-Forming Reactions Date of Original Submission: April 2006 Date of Current Report: February 2009. Background of Work Project.
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Fundamental Understanding of Sulfonate Ester-Forming Reactions
Date of Original Submission: April 2006
Date of Current Report: February 2009
Concern exists that sulfonate esters may be genotoxic impurities and are potentially formed during drug substance manufacturing when sulfonic acids are used in the presence alcoholic solvents
The elimination of sulfonic acids from drug substance manufacturing would be highly undesirable due to its useful synthetic properties
The amount of sulfonate esters formed under synthetically relevant conditions is currently unclear
Bob Evans, AAPS, synthetic chemist
Sue Jones, PDA, analytical chemist
George Smith, FDA, CDER
This work may be extended to other relevant solvent systems
What is the cost/benefit ratio of doing so?