NEW CRYSTALLINE FORM OF (S)-BEPOTASTINE P-TOLUENESULFONIC ACID SALT AND THE PROCESS FOR PREPARING THEREOF

摘要

The present invention relates to new anhydrous crystalline forms A and B and a monohydrate crystalline form C of (S)-bepotastine p-toluenesulfonate, and a method for preparing the same. The anhydrous crystalline forms A and B and the monohydrate crystalline form C of (S)-bepotastine p-toluenesulfonate, according to the present invention, have excellent solubility and effectively maintain optical stability, thereby being formulated reliably without reducing pharmaceutically active substances and being stored for a long period.