SPL Set ID: 136ad992-2e39-dad9-e063-6294a90adcc6

The active ingredient in lansoprazole delayed-release capsules 15 mg and 30 mg is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16 H 14 F 3 N 3 O 2 S with a molecular weight of 369.37. Lansoprazole has the following structure: Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsule form, for oral administration in two strengths 15 mg and 30 mg. Lansoprazole delayed-release capsules are available in two strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains lansoprazole delayed-release pellets 8.5% consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: acetone, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sugar spheres (consists of sucrose and corn starch), talc and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 15 mg contains D&C Red 28, FD&C Blue 1, FD&C Green 3, FD&C Red 40, gelatin, purified water and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 30 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, gelatin, purified water and titanium dioxide. The white printing ink contains ammonia, potassium hydroxide, propylene glycol, shellac and titanium dioxide Structure