Case Study 6

A Client observed a more than 10% of a high molecular weight impurity during the large-scale manufacture of an Active Pharmaceutical Ingredient (API). A Redox-Neutral Alcohol-Amine Coupling reaction was a potential alternative process replacing the SN2 displacement of a tosylate. The Redox Neutral coupling removes the Potential Genotoxic Impurity (PGI).

A Redox-Neutral Alcohol-Amine Coupling reaction was developed as an alternative synthesis of an Active Pharmaceutical Ingredient (API). The combination of DoE and PCA allowed the rapid assessment of the alternative catalytic system for the API. An additional assessment showed that the reaction worked well but the required high catalyst loading made the reaction economically unviable. The whole process took less than 2 weeks to demonstrate the viability of the route and make a clear decision on the cost effectiveness of the reaction.

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