SPL Set ID: c98e40ec-8a2c-4f19-b1c3-c82f708c2490
1 drug(s) with this SPL Set ID
The active ingredient in atazanavir capsules is atazanavir sulfate USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3 S ,8 S ,9 S ,12 S )-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13- pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C 38 H 54 N 6 O 11 S, which corresponds to a molecular weight of 802.93 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula: Atazanavir sulfate USP is a white to pale yellow crystalline powder. It is freely soluble in methanol and practically insoluble in water. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate USP, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue No. 2, FD & C Yellow 6, iron oxide yellow, and titanium dioxide. The capsules are printed with ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, and titanium dioxide. Atazanavir Structure