SPL Set ID: 1bb94d3c-8bc3-4193-9dd8-e9a22066707c

The active ingredient in pantoprazole sodium for injection (pantoprazole sodium), a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 16 H 14 F 2 N 3 NaO 4 S, with a molecular weight of 405.4. The structural formula is: Pantoprazole sodium USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, in methanol, in dehydrated alcohol, very slightly soluble in phosphate buffer at pH 7.4, practically insoluble in hexane and in dichloromethane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The reconstituted solution of pantoprazole sodium for injection is in the pH range 9.0 to 10.5. Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 42.3 mg of pantoprazole sodium USP), edetate disodium (1 mg), and sodium hydroxide to adjust pH. pantoprazolesodiumforinjstructure