Synthesis and Characterization of Related Substances of Deferasirox, an Iron (Fe³⁺) Chelating Agent

Abstract

Deferasirox is an orally active iron chelating agent, and during process development for deferasirox, we observed six related substances (impurities), namely deferasirox methyl ester, deferasirox salicylyl derivative, deferasirox ethyl ester, deferasirox methoxy carbonyl derivative, bis(salicyl)imide, and deferasirox-2-isomer. The present work describes the detection, origin, synthesis, and characterization of these related substances.

GRAPHICAL ABSTRACT

Keywords:

• Deferasirox
• iron (Fe³⁺) chelating agent
• related substances and synthesis

ACKNOWLEDGMENTS

The authors gratefully acknowledges the management of Aurobindo Pharma Limited for allowing us to carry out this research work. The authors are also thankful to the colleagues of the Chemical Research Department and Analytical Research Department for their cooperation.