SPL Set ID: 4dbfcc02-dacc-4f0c-9f41-095783b68e27

Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N -[2-(Diethylamino)ethyl]-5-[( Z )-(5-fluoro-2-oxo-1,2-dihydro-3 H -indol-3-ylidene)methyl]-2,4-dimethyl-1 H -pyrrole-3-carboxamide hydrogen (2 S )-2-hydroxybutanedioate. The molecular formula is C 22 H 27 FN 4 O 2 • C 4 H 6 O 5 and the molecular weight is 532.6. The chemical structure of sunitinib malate is: Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard-shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, mannitol, sodium lauryl sulfate and titanium dioxide. The 12.5 mg and 25 mg strengths also contain red iron oxide. The 25 mg, 37.5 mg and 50 mg strengths also contain yellow iron oxide. In addition, the black imprinting ink contains the following: ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Sunitinib Structural Formula