Synthesis and Characterization of Potential Impurities of Canagliflozin

Abstract

Multiple sources of anticipated process and degradation impurities of canagliflozin drug has been identified during its laboratory optimization and later in commercial scale manufacturing process. The structure of these impurities were confirmed by their independent synthesis as well as by their complete spectral characterization including 2D NMR, 19F NMR, and their chromatographic retention time profile. As a part of these investigations, three new impurities such as Hydroperoxide (Impurity‐D), Sulfone (impurity‐F) and Dimer (impurity‐C) were characterized. The present work describe our detailed investigations on the structural characterization of canagliflozin impurities, and further their independent synthesis.