METHOD FOR MANUFACTURING CRYSTALLINE FORM (I) OF CLOPIDOGREL HYDROGEN SULPHATE

摘要

PURPOSE: A method for preparing a crystalline form of clopidogrel hydrogen sulphate(I) is provided to prepare a crystal with excellent fluidity and to minimize cracking. CONSTITUTION: A method for preparing a crystalline form of clopidogrel hydrogen sulphate comprises: a step of reacting clopidogrel free base with dark sulfuric acid under the presence of mixture solvent of 2-butanol and water. The use of waer is 5-14 weight% based on a weight of clopidogrel free base. The method additionally comprises a step of seeding the crystalline form(I) of clopidogrel hydrogen sulphate.