Tuesday, March 30, 2010

Fine example of QbD: Detailed Study of Sulfonate Ester Formation and Solvolysis Reaction Rates

Credit is due to Dr Ed Delaney (Reaction Science Consulting LLC) and his co-workers from an array of top pharmaceutical companies for their recent publications on sulfonate ester formation.

From the outset the team, which was supported by PQRI, was determined to develop a mechanistic understanding to underpin guidance on this important industry and public health issue. Kinetic models were developed alongside detailed experiments (in which the ester formation reactions were followed with frequent sampling) to inform and direct experimentation before reaching strongly supported conclusions and guidelines for the industry.

The paper is a fine example of a science and risk-based approach, in which "kinetic models are presented that should be of value to process development scientists in designing appropriate controls in situations where risk for sulfonate ester formation does exist".

More at: http://pubs.acs.org/doi/abs/10.1021/op900301n#aff2

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