SPL Set ID: e79725fe-54c8-4dcb-a03a-0c91cc20cf77

The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is 1H-Benzimidazole-5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), dihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg x 2 H 2 O with molecular weight of 749.15 g/mol as a dihydrate and 713.15 g/mol on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored powder. It is slightly soluble in methanol, practically insoluble water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains either 20 mg or 40 mg of esomeprazole (present as 21.75 mg or 43.5 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets containing the following inactive ingredients: hydroxypropyl cellulose, hypromellose, methacrylic acid - ethyl acrylate copolymer, polyethylene glycol, sugar spheres (comprised of sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The capsule shells contain the ingredients FD&C blue# 1, gelatin, iron oxide yellow, shellac, sodium lauryl sulfate, and titanium dioxide. Additionally, black ink contains black iron oxide and potassium hydroxide. Meets USP dissolution test 2. structure