Identification and Synthesis of Flecainide Acetate Impurities and Its Control to ICH Limit

The improved synthesis of Flecainide acetate (I) is conferred in this article. The chief intent to present this article is to identify and synthesis of the process related impurities of Flecainide acetate.

The article also provides the complete study and characterization of the process impurities. Most of the impurities are the in-situ generated intermediates which are tend to carryforward to the final step of synthesis. The more interesting part is the formation of 2,5 –bis (2,2,2-trifluoroethoxy)-N-((4-methylpiperidine-2-yl) methyl) benzamide impurity during Flecainide acetate synthesis.

The article confers the synthesis of 2,5 –bis (2,2,2-trifluoroethoxy)-N-((4-methylpiperidine-2-yl) methyl) benzamide and its control in Flecainide acetate.