The present invention relates to dabigatran etexilate and related substances and use of the substances as reference standards and markers. There are also provided processes of detecting the substances in samples of dabigatran etexilate, or pharmaceutically acceptable salts or solvates thereof, and also for analyzing the purity of samples of dabigatran etexilate, or pharmaceutically acceptable salts or solvates thereof. There are still further provided processes of preparing dabigatran etexilate and related substances, and pharmaceutical compositions containing the same.
本发明涉及
达比加群酯和相关物质,以及将这些物质用作参考标准和标记的用途。还提供了检测
达比加群酯或其药学上可接受的盐或溶剂的样品中这些物质的过程,以及分析
达比加群酯或其药学上可接受的盐或溶剂的样品纯度的过程。还提供了制备
达比加群酯和相关物质以及含有它们的制药组合物的过程。