A new method of obtaining chemically pure and pharmaceutically acceptable Dabigatran Etexilate or its pharmaceutical acceptable salt having purity at least about 99% is provided, wherein the content of Dabigatran Etexilate individual impurity is less than 0.03-0.15% as measured by HPLC. A method of removing specific impurities that are generated either due to the intrinsic instability of Dabigatran Etexilate or in process of its preparation is provided too.
提供了一种获得
化学纯和药学可接受的
达比加群胺
乙酯或其药学可接受的盐的新方法,其纯度至少为约99%,其中
达比加群胺
乙酯个体
杂质的含量小于0.03-0.15%,通过HPLC测量。还提供了一种去除特定
杂质的方法,这些
杂质是由
达比加群胺
乙酯的固有不稳定性或制备过程中产生的。