SPL Set ID: 48169bbc-4fb2-4bc4-9bdd-de71bf7722df
1 drug(s) with this SPL Set ID
Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white powder. Topiramate, USP is the most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in dichloromethane. The solubility in water is 10.1 mg/mL. Its saturated solution has a pH of 5.32. Topiramate, USP has the molecular formula C 12 H 21 NO 8 S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5- Di- O -isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Topiramate capsules, USP contain topiramate-coated beads in a hard gelatin capsule. The inactive ingredients are hydroxypropyl methylcellulose, sugar spheres (sucrose and starch), purified water, ethyl cellulose, polyethylene glycol, talc, ammonium hydroxide, medium chain triglycerides, oleic acid, gelatin, titanium dioxide. The black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP. image description