SPL Set ID: 78ce3df5-07ee-43bb-9348-104a9524a032

Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17 H 14 F 3 N 3 O 2 S, and it has the following chemical structure: Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: lactose monohydrate, crospovidone, sodium lauryl sulphate, polyvinyl pyrrolidone, magnesium stearate and gelatin. The gelatin capsule shell of the 50 mg strength contains gelatin, iron oxide red, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The gelatin capsule shell of the 100 mg strength contains FD&C blue 1, FD&C red 40, gelatin, sodium lauryl sulfate and titanium dioxide. The gelatin capsule shell of the 200 mg strength contains gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The gelatin capsule shell of the 400 mg strength contains FD&C blue 1, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The dyes of the imprinting ink for 50 mg, 100 mg, 200 mg and 400 mg strength contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, shellac and strong ammonia solution. celecoxib-spl-structure