Strategies For Controlling Genotoxic Impurities And LCMS/MS Method Development For Quantifying TTC Levels In Rebamipide Synthesis

Abstract

The key research investigates strategies for controlling of potential genotoxic impurity (PGI) to the desired limit by reducing the genotoxic functionality to non-PGI functionality and elimination of non-PGI functionality by converting to its acid salt and removing it by dissolving in water/solvent. This investigation work is approached during the synthesis of Rebamipide and it was free from the PGI. The robust LC-MS/MS method was developed for identification and quantification of mentioned PGI at TTC limit. The characterization data and the control of PGI at TTC level are reported