SPL Set ID: 810dfcb2-d35b-4971-887c-2e78e82e9e07

Sunitinib is a kinase inhibitor present in sunitinib malate capules as the malate salt. Sunitinib malate is described chemically as (2 S )-2-hydroxybutanedoic acid with N -[2-(diethylamino)ethyl]-5-[( Z )-(5-fluoro-1,2-dihydro-2-oxo- 3H -indol-3-ylidine)methyl]-2,4-dimethyl- 1H -pyrrole-3-carboxamide (1:1). 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 Daltons. 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 16.71 mg, 33.41 mg, 50.12 mg, or 66.83 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone. The red opaque gelatin capsule shells contain gelatin, iron oxide red, and titanium dioxide; the olive green opaque gelatin capsule shells contain FD&C Blue 2, gelatin, iron oxide red, iron oxide yellow, and titanium dioxide; and the light green opaque gelatin capsule shells contain FD&C Blue 2, gelatin, iron oxide yellow, and titanium dioxide. The white printing ink contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide and the black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. sunitinib-str