SPL Set ID: 0c6e00a2-31e8-4e84-928d-80e69a5fc634
1 drug(s) with this SPL Set ID
The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 17 H 19 N 3 O 3 S, with a molecular weight of 345.42. The structural formula is: Omeprazole USP is a white to off-white powder that melts with decomposition at about 150°C to 160°C. Soluble in dichloromethane, sparingly soluble in methanol and in alcohol. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg or 20 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: colloidal silicon dioxide, dibasic sodium phosphate anhydrous, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, lactose monohydrate, low-substituted hydroxypropyl cellulose, mannitol, microcrystalline cellulose, sodium lauryl sulphate, talc and triethyl citrate. The capsule shells have the following inactive ingredients: D&C Red 28, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, gelatin, sodium lauryl sulphate and titanium dioxide. The imprinting ink contains the following ingredients black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. FDA approved dissolution test specifications differ from the USP. omeprazolestructure