Abstract

IDENTIFICATION, CHARACTERIZATION AND SYNTHESIS OF IGURATIMOD PROCESS AND DEGRADATION RELATED IMPURITIES

Bharat B. Kashid, Kishor R. More*, Brajesh Sharma and Anil A. Ghanwat

Abstract

A synthesis process developed to produce safe and high purity Iguratimod API. As per regulatory requirement the obtained API subjected to stress test for profiling the plausible impurities and its route of formation. During these studies total of four impurities related to process, forced degradation and OVI were observed. Three of these impurities were detected by HPLC and one by GC. Further these impurities were isolated and subjected to LC-MS, GC-MS and NMR studies. For absolute confirmation these impurities were synthesized and profiled.

Keywords: Iguratimod, methyl impurity, 5-phenoxybenzoic acid impurity, amine impurity, acetaimidine.