SYNTHESIS AND CHARACTERIZATION OF POTENTIAL IMPURITIES OF DEFERASIROX

Deferasirox (1) is an orally active iron chelating agent, invented by Novartis AG. During process development for deferasirox, we observed four related substances (impurities) namely deferasirox methyl ester (2), deferasirox ethyl ester (3), bis(salicyl)imide compound (4) and cyclic poly ester compound (5). The present work describes synthesis, characterization and analytical condition for detection and purity of these impurities.