Process for the manufacture of lyophilised dabigatran, lyophilised dabigatran obtained by the process, its use as a calibrating agent and in an anticoagulation assay and a kit comprising it

摘要

The invention relates to a lyophilised form of dabigatran of formula I its use as a calibrator in the assays for the determination of pharmacodinamic effects of dabigatran etexilate as well as such assays per se.