SPL Set ID: 5823b3a2-3256-4d94-97b4-ec6b940312f4

Ropinirole tablets contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16 H 24 N 2 O•HCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is: Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243 o C to 250°C and a solubility of 133 mg/mL in water. Each round biconvex film-coated ropinirole tablet contains 0.29, 0.57, 1.14, 2.28, 3.42, 4.56, or 5.70 mg of ropinirole hydrochloride equivalent to ropinirole 0.25, 0.5, 1, 2, 3, 4, or 5 mg, respectively. Inactive ingredients of the core tablets consist of croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Inactive ingredients of the film coats are slightly different among the 7 strengths of tablets and are tabulated below: Strength Inactive ingredients of the film coat 0.25 mg lecithin (soya), polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc and titanium dioxide. 0.5 mg iron oxide yellow, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc and titanium dioxide. 1 mg FD&C Blue No. 2 aluminum lake, iron oxide yellow, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc and titanium dioxide. 2 mg lecithin (soya), iron oxide red, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc and titanium dioxide. 3 mg carmine, FD&C Blue No. 1 aluminum lake, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc and titanium dioxide. 4 mg iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc and titanium dioxide. 5 mg FD&C Blue No. 2 aluminum lake, lecithin (soya), polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP. structural formula