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.
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