SPL Set ID: 340b57c2-bcf8-4f46-b522-886daaf80351

1 drug(s) with this SPL Set ID

Open DailyMed details

Pantoprazole Sodium PANTOPRAZOLE SODIUM
#14 40 mg Injection
FRESENIUS KABI USA, LLC FDA Rx Only

The active ingredient in Pantoprazole Sodium for Injection, a PPI, is 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl) methyl]sulfinyl]-1H-benzimidazole, sodium salt, hydrate (2:3), a compound that inhibits gastric acid secretion. Its empirical formula is C 16 H 14 F 2 N 3 NaO 4 S, 1 1/2 H 2 O, with a molecular weight of 432.4. The structural formula is: Pantoprazole sodium, USP is a white to almost white powder and is racemic. Pantoprazole sodium is freely soluble in water and in ethyl alcohol, and practically insoluble in hexane. 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 9.5 to 11.5. Pantoprazole Sodium for Injection is supplied for intravenous administration as a sterile white to off-white cake or powder in a single-dose clear flint tubing glass vial, stoppered with lyo rubber closure, sealed with aluminum flip-off overseal. Each vial contains 40 mg pantoprazole (45.1 mg pantoprazole sodium, USP equivalent to 40 mg pantoprazole), and sodium hydroxide to adjust pH. description

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