SPL Set ID: a03aa46f-9eb5-4cf4-addf-745d94af8261
1 drug(s) with this SPL Set ID
The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1 H -benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16 H 14 F 2 N 3 NaO 4 S × 1.5 H 2 O, with a molecular weight of 432.4. The structural formula is: Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet contains 45.1 mg or 22.55 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, talc, titanium dioxide, and triethyl citrate. The 20 mg tablet also contains black iron oxide, isopropyl alcohol, and propylene glycol. Pantoprazole Sodium Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 4. Chemical Structure