NMR reaction monitoring during the development of an active pharmaceutical ingredient

Abstract

We show the use of NMR spectroscopy to develop detailed understanding of a reaction mechanism during development of a manufacturing process for an active pharmaceutical ingredient (API). This includes structural elucidation of reaction starting materials, intermediates and products. The method is able to generate an immediate mass balance through quantitative profiling of all materials involved in the reaction. A straightforward reaction monitoring methodology was employed using existing laboratory based equipment.