Synthesis and Characterization of Impurity B of S-(+)-Clopidogrel Bisulfate: An Antiplatelet

Abstract

S-(+)-Clopidogrel bisulfate [(S-(+)-methyl 2-(2-chlorophenyl)-2-(6, 7-dihydrothieno[3, 2-c]pyridin-5(4H)-yl)acetate bisulfate)] is a platelet aggregation inhibitor drug. S-(+)-Clopidogrel bisulfate is prepared by different synthetic approaches in the literature. In almost all the approaches the major impurities known in the literature (A, B, and C) are also listed in the U.S. pharmacopoeia. The control of these pharmaceutical impurities is currently a critical issue to the pharmaceutical industry. In this article, a description of these impurities and their origins in the S-(+)-clopidogrel bisulfate process are presented along with the preparation of impurity B.

GRAPHICAL ABSTRACT

Keyword:

• Antiplatelet
• impurity B
• S-(+)-clopidogrel bisulfate