SPL Set ID: b573aefa-e337-478f-97e4-eb8472a7e497

Clopidogrel bisulfate, USP is a thienopyridine class inhibitor of P2Y 12 ADP platelet receptors. Chemically it is methyl (+) - (S) – α - (2-chlorophenyl) - 6,7-dihydrothieno [3,2-c]pyridine- 5(4H)-acetate, sulfate (1:1). The empirical formula of clopidogrel bisulfate, USP is C 16 H 16 ClNO 2 S•H 2 SO 4 and its molecular weight is 419.90. The structural formula is as follows: Clopidogrel bisulfate, USP is an off-white to white colored powder. It is insoluble in water, hence pH value is not determined. It is freely soluble in methanol. It has a specific optical rotation of about +52°. Clopidogrel Tablets, USP for oral administration are provided as either pink, round, bevel edged, biconvex, imprinted, film-coated tablets containing 97.875 mg of clopidogrel bisulfate, USP which is the molar equivalent of 75 mg of clopidogrel base or pink, capsule shaped, biconvex, imprinted, film-coated tablets containing 391.500 mg of clopidogrel bisulfate, USP which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, crospovidone, hydrogenated castor oil, lactose monohydrate, low substituted hydroxy propyl cellulose, mannitol, microcrystalline cellulose and polyethylene glycol as inactive ingredients. The tablets are coated with Opadry II Pink which contains hypromellose, lactose monohydrate, iron oxide red, titanium dioxide and triacetin. The film-coated tablets are imprinted with Opacode Black which contains ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac in ethanol. clopidogrel-structure