SPL Set ID: 927cba3a-62cf-4e9f-9871-92835927ea46

Oseltamivir phosphate capsules,USP an influenza neuraminidase inhibitor (NAI), is available as: • Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate USP. In addition to the active ingredient, each capsule contains croscarmellose sodium, pregelatinized starch, polyvinylpyrrolidone, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, iron oxide yellow and titanium dioxide. The 45 mg capsule shell contains gelatin, iron oxide black and titanium dioxide. The 75 mg capsule shell contains gelatin, iron oxide yellow, iron oxide black, and titanium dioxide. Each capsule is printed with blue ink, which includes FD & C Blue # 2 aluminum lake and shellac as the colorant. Oseltamivir phosphate USP, is a White to off-white solid with the chemical name (3 R ,4 R ,5 S )-4-acetylamino-5-amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid ethyl ester phosphate (1:1). The chemical formula is C 16 H 28 N 2 O 4 .H 3 PO 4 . The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows: Meets USP Dissolution Test 2. oseltamivir-structure