SPL Set ID: 0169dbda-53df-4cd9-b989-ff7544f1bdf5

Pomalidomide is a thalidomide analog. The chemical name is ( RS )-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure: The empirical formula for pomalidomide is C 13 H 11 N 3 O 4 and the gram molecular weight is 273.25. Pomalidomide is a light yellow to yellow colored powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide capsules are available in 1-mg, 2-mg, 3-mg, and 4-mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: mannitol, pregelatinized starch, croscarmellose sodium and sodium stearyl fumarate. The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, white ink and black ink. The 2-mg capsule shell contains gelatin, FD&C Blue #2, titanium dioxide, iron oxide yellow, FD&C Red #3, and white ink. The 3-mg capsule shell contains gelatin, FD&C Blue #2, titanium dioxide, iron oxide yellow, and white ink. The 4-mg capsule shell contains gelatin, FD&C Blue #2, titanium dioxide, and white ink. Black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. White ink contains Shellac, ethanol, isopropyl alcohol, n-butanol, propylene glycol, ammonia solution, purified water, potassium hydroxide, and titanium dioxide. structure