Sulfuric Acid → Clopidogrel Bisulfate

Participants

Reaction Conditions

Reaction Steps

Clopidogrel base (50 gms) was dissolved in n-heptanol (154 mL) with stirring at 25 to 30° C. and dilute H2SO4 was added at 10-15° C. The reaction mixture was seeded with form-I crystal at 20-25° C. The reaction mixture was stirred at room temperature, for 20-24 hrs, filtered, washed with methyl tert-butyl ether (50 ml) and dried at temperature in the range from 30 to 35° C. in a drier, to get 50 g of Clopidogrel bisulfate salt as crystals. Subsequent analysis confirmed that the crystals were Clopidogrel hydrogen sulfate Form-I.

Provenance & Evidence