The present disclosure relates to a process of preparing Ivabradine Hydrochloride, which is devoid of product related impurities. More specifically, the present disclosure provides a process to obtain a new polymorph of Ivabradine Hydrochloride, wherein said polymorph is pure and devoid of impurities at particular RRTs. The disclosure further relates to the removal of specific impurities of Formula 8 and/or Formula 9 during the preparation of said Ivabradine Hydrochloride. The disclosure also specifically provides the said polymorphic form of Ivabradine Hydrochloride.
本公开涉及一种制备
盐酸伊伐布雷定的过程,该过程不含产品相关杂质。更具体地,本公开提供了一种获得新的
盐酸伊伐布雷定多晶形态的过程,其中所述多晶形态是纯净的,在特定的RRT下不含杂质。本公开进一步涉及在制备所述
盐酸伊伐布雷定的过程中去除特定的Formula 8和/或Formula 9的杂质。本公开还特别提供了所述
盐酸伊伐布雷定的多晶形态。