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US 2007/0191609 A1Published application
Process for preparation of clopidogrel bisulphate form-1
AssigneeLee Pharma Limited
InventorsVenkat Reddy ALLA, Kameshwara Rao VYAKARANAM, Aruna Kumari SIRIGIRI, Srinivas Reddy BODAPATI, Ranadheer Reddy BILLA, Saikrishna Reddy GUDIBANDI, Raghumitra ALLA
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Abstract
Disclosed herein is a cost effective and industrially feasible process for the preparation of (+) Clopidogrel bisulphate. The present invention further discloses a novel method of precipitation of (+) Clopidogrel bisulphate Form I directly from solvent mix of methanol and acetone in presence of sulfuric acid at a temperature of 25-40° C.
Claims9
The method of preparation of clopidogrel bisulphate Form I characterized in that the process;
- a. using low ratio of 1:1 of 2-chloro phenyl glycine to thionyl chloride to get 2-chloro phenyl glycine methyl ester in presence of methanol;
- and
- b. directly precipitating clopedogrel bisulfate form 1 from mixture of solvents such as methanol and acetone in presence of sulfuric acid at a temperature ranging between 25° to 40° C., more preferably 30°-32° C.
Dependencies are inferred from the claim text.