SPL Set ID: 916dfac8-da11-40e4-9e44-a909e29a6b5f

Lomustine Capsules, USP (lomustine) is an alkylating drug for oral administration. The chemical name for lomustine is 1-(2-chloro-ethyl)-3-cyclohexyl-1-nitrosourea and the molecular formula is C 9 H 16 ClN 3 O 2 . The molecular weight is 233.71. Lomustine is a yellow powder, which is soluble in 10% ethanol (0.05 mg per mL) and in absolute alcohol (70 mg per mL). Lomustine is insoluble in water (<0.05 mg per mL). The chemical structure is: Lomustine Capsules, USP are supplied as 10 mg, 40 mg, and 100 mg capsules and contain the following inactive ingredients: magnesium stearate NF and mannitol USP. The 10 mg capsule shells are composed of gelatin and titanium dioxide. The 40 mg and 100 mg capsule shells are composed of FD&C blue #1, gelatin, iron oxide black, iron oxide yellow, and titanium dioxide. The capsules are printed with black ink composed of iron oxide black, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. FDA approved dissolution method is not listed in the USP Monograph for Lomustine Capsules, USP, 10 mg, 40 mg, and 100 mg. image description