SYNTHESIS OF HIGH PURE TICAGRELOR, AN ANTIPLATELET DRUG SUBSTANCE AND ITS POSSIBLE PROCESS RELATED IMPURITIES

S. Venkat Rao, Rajeev Kumar Dubey, Ch. Anil Kumar, M. Sudheer Reddy, M. Narendar and Ramesh Babu Potluri SMS Pharmaceuticals Ltd, R&D Center (A DSIR Approved), Gagillapur (V), Telangana state-500043, India. *E-mail: venkat@smspharma.com; svr.org@gmail.com ABSTRACT Cost effective, robust manufacturing process is developed for N-alkylation of compound 6 and 7 with commercially available reagent/base like DBU, TEA and ethanol used as a solvent. The most important development is high pure pharma product Ticagrelor was achieved by purifying in mixture of Methanol and Water. As per ICH guidelines all known and unknown impurities limits below NMT 0.10% achieved with excellent yield (75%) and Quality 99.9%.