Process for preparing 5-2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl-4,5,6,7-tetrahydrothieno3,2-cpyridin-2-yl acetate hydrochloride (prasugrelu hydrochloride in polymorphous B form

摘要

The present invention relates to a process for the preparation of 5- [2-cyclopropyl-1- (2-fluorophenyl) -2-oxoethyl] -4,5,6,7-tetrahydrothieno [3,2-c] pyridin-2-yl acetate hydrochloride of formula I (prasugrel hydrochloride) in crystalline form B, wherein prasugrel base of formula II is dissolved or suspended in an organic solvent and reacted with hydrogen chloride dissolved in an organic solvent or water at a temperature in the range of -20 ° C to 75 ° C. C, and optionally after addition of the co-solvent, crystallizes.