SPL Set ID: dbcd423f-91fe-4a06-bf31-9e01ad68b7b0

The active ingredient in lansoprazole delayed-release capsules 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 molecular 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, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; and practically insoluble in 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 and approximately 18 hours at pH 7. Each lansoprazole delayed-release capsule, USP intended for oral administration contains 15 mg or 30 mg of lansoprazole. In addition, each capsule contains the following inactive ingredients: corn starch, D&C red # 28, FD&C blue # 1, FD&C red # 40, gelatin, hydroxypropyl cellulose, hypromellose, low substituted hydroxypropyl cellulose, magnesium carbonate heavy powder, methacrylic acid copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc and titanium dioxide. The capsule shell is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.