SPL Set ID: f2657911-6f06-71fb-e053-2a95a90ae6f7
1 drug(s) with this SPL Set ID
Each mesalamine extended-release capsule is a delayed-and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each mesalamine extended-release capsules, USP contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules USP are microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer nonoxynol 100 dispersion, colloidal silicon dioxide, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, sodium lauryl sulphate, talc, triethyl citrate, hypromellose, titanium dioxide, polyethylene glycol, vanillin, gelatin, FD and C Blue # 1, FD and C Red #3, edible black ink which contains shellac, propylene glycol, black iron oxide, potassium hydroxide. FDA approved dissolution test specifications differ from USP acceptance criteria mesalamine-structure