Development of a Control Strategy for a Defluorinated Analogue in the Manufacturing Process of Casopitant Mesylate

…, P Stonestreet, A Galgano, P Westerduin

Index: Bravo, Fernando; Cimarosti, Zadeo; Tinazzi, Francesco; Castoldi, Damiano; Stonestreet, Paul; Galgano, Annalisa; Westerduin, Pieter Organic Process Research and Development, 2010 , vol. 14, # 4 p. 832 - 839

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Citation Number: 2

Abstract

Casopitant mesylate was identified as part of the search for drugs with activity on the Central Nervous System (CNS) by GlaxoSmithKline. During late-phase development studies to develop the manufacturing process, a new impurity was found. This synthetic impurity, a defluorinated analogue of the drug substance, is discussed in detail to show the process development studies carried out to ensure quality control for the final drug substance ...