Development of processes to manufacture active pharmaceutical ingredients (APIs) brings distinct challenges, even beyond those of earlier transformations in their total synthesis. Both saxagliptin and asunaprevir brought unique challenges in their respective syntheses.  The development of these two APIs will be discussed, with an emphasis on mechanistic understanding, impurity formation and control, crystal form, and stability.  Robust manufacturing processes will be presented that are supported by a history of thousands of kilograms of drug substance produced over years of processing.<br/>

Synthetic challenges in the development of commercial manufacturing processes for two active pharmaceutical ingredients

252nd National Meeting (2016)

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