SPL Set ID: bb78f952-69a5-1620-e053-2a95a90afe97

Prasugrel tablets, USP contain prasugrel, a thienopyridine class inhibitor of platelet activation and aggregation mediated by the P2Y 12 ADP receptor. Prasugrel tablets are formulated as the hydrochloride salt, a racemate, which is chemically designated as 5-[(1RS)-2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride. Prasugrel hydrochloride has the molecular formula C 20 H 20 FNO 3 S•HCl representing a molecular weight of 409.90. The chemical structure of prasugrel hydrochloride is: Prasugrel hydrochloride, USP is a white to light brown crystalline solid. It is soluble at pH 2, slightly soluble at pH 3 to 4, and practically insoluble at pH 6 to 7.5. It also dissolves freely in methanol and is slightly soluble in 1- and 2-propanol and acetone. It is practically insoluble in diethyl ether and ethyl acetate. Prasugrel tablets are available for oral administration as 5 mg or 10 mg capsule shaped, film-coated, unscored tablets, debossed on each side. Each yellow 5 mg tablet is manufactured with 5.49 mg prasugrel hydrochloride, equivalent to 5 mg prasugrel and each brown 10 mg tablet with 10.98 mg prasugrel hydrochloride, equivalent to 10 mg of prasugrel. Other ingredients include crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, mannitol, pregelatinized starch (corn), sucrose stearic acid esters, titanium dioxide, triacetin and yellow iron oxide. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake. The 10 mg tablets also contain black iron oxide and red iron oxide. Meets USP Dissolution Test 2. Prasugrel Hydrochloride Structural Formula