Dabigatran Etexilate Mesilate and its Impurities

Dabigatran etexilate mesilate is the oral prodrug form of dabigatran, a direct thrombin inhibitor used as an anticoagulant. It is marketed under the brand name Pradaxa and is available in capsule and oral pellet forms. Reference standards of Dabigatran Etexilate Mesilate API,and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.