The present invention describes an improved industrial process for crystallizing polymorph Form I of (+) clopidogrel hydrogen sulphate (also called clopidogrel bisulphate) in either a Type-I solvent or a Type-II. Type I solvent is an organic solvent containing two or more functional groups with a proviso that at least one functional group is different from the other(s). The Type II solvent is selected from methyl ethyl ketone, cyclopentylmethyl ether, dipropylglycolether, dibutylglycol ether, propylmethyl cellosolve, butylmethylcellosolve, propylethylellosolve, butylethylcellosolve or their cross combinations. The process produces Form I in a reproducible manner without detectable contamination of polymorph designated as Form II.
本发明描述了一种改进的工业过程,用于在Type-I溶剂或Type-II中结晶(+)噻
氯匹多巴
氢硫酸盐的多形式I(也称为噻
氯匹多巴双
硫酸盐)。Type I溶剂是一种有机溶剂,含有两个或两个以上的功能基团,但至少有一个功能基团与其他功能基团不同。Type II溶剂从甲基乙酮、
环戊基甲醚、二丙基
乙二醇醚、二丁基
乙二醇醚、丙基甲基赛洛索、丁基甲基赛洛索、丙基乙基赛洛索、丁基乙基赛洛索或它们的交叉组合中选择。该过程以一种可重复的方式产生多形式I,而没有检测到被指定为形式II的多形式的污染。