SPL Set ID: dd47a015-ff90-d7a7-8dcb-4e6e31a68071

The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N -[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1 H -benzimidazol-5-yl]carbonyl]- N -2-pyridinyl-ethyl ester, methanesulfonate. The molecular formula is C 34 H 41 N 7 O 5 ●CH 4 O 3 S and the molecular weight is 723.86 g/mol. The structural formula is: Dabigatran etexilate mesylate is a yellow to white powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol, very slightly soluble in acetone, practically insoluble in ethyl acetate. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 172.97 mg dabigatran etexilate mesylate, which is equivalent to 150 mg of dabigatran etexilate, 126.86 mg dabigatran etexilate mesylate, which is equivalent to 110 mg dabigatran etexilate, or 86.49 mg dabigatran etexilate mesylate which is equivalent to 75 mg dabigatran etexilate. The capsule fill also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, fumaric acid, magnesium stearate and mannitol. The capsule shell is composed of FD&C blue No.1, hypromellose, iron oxide red, iron oxide yellow, titanium dioxide and edible black ink which consists of non-volatile ingredients ammonium hydroxide, iron oxide black, potassium hydroxide, propylene glycol and shellac. dabigatran etexilate structure