SPL Set ID: 78c12889-c837-40c1-8f85-4d048008ad29

Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]- as -tetrazine-8-carboxamide. The structural formula of temozolomide is: The material is a white to light pink or light tan powder with a molecular formula of C 6 H 6 N 6 O 2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence temozolomide capsules can be administered orally. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients are anhydrous lactose, colloidal silica, sodium starch glycolate, stearic acid, tartaric acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Temazolomide Capsules USP, 5 mg: The opaque green cap contains FD&C Blue #2, gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 20 mg: The opaque yellow cap contains gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsule USP, 100 mg: The opaque pink cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules, USP, 140 mg: The opaque blue cap contains FD&C Blue #2, gelatin, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 180 mg: The opaque orange cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 250 mg: The opaque white cap contains gelatin, sodium lauryl sulfate, and titanium dioxide. temozolamidecapsulesstructure