SPL Set ID: 27e5a781-e4f2-4489-9def-7971d0b86d9c

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 tan/light pink 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, USP 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: Temozolomide capsules, USP for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: Temozolomide capsules, USP, 5 mg: lactose anhydrous (103.52 mg), colloidal silicon dioxide (0.180 mg), sodium starch glycolate (5.650 mg), tartaric acid (2.260 mg), and stearic acid (3.390 mg). Temozolomide capsules, USP, 20 mg: lactose anhydrous (179.0 mg), colloidal silicon dioxide (0.320 mg), sodium starch glycolate (10.350 mg), tartaric acid (4.140 mg), and stearic acid (6.210 mg). Temozolomide capsules, USP, 100 mg: lactose anhydrous (73.0 mg), colloidal silicon dioxide (0.280 mg), sodium starch glycolate (9.00 mg), tartaric acid (3.60 mg), and stearic acid (5.40 mg). Temozolomide capsules, USP, 140 mg: lactose anhydrous (102.2 mg), colloidal silicon dioxide (0.390 mg), sodium starch glycolate (12.60 mg), tartaric acid (5.040 mg), and stearic acid (7.560 mg). Temozolomide capsules, USP, 180 mg: lactose anhydrous (131.4 mg), colloidal silicon dioxide (0.500 mg), sodium starch glycolate (16.20 mg), tartaric acid (6.480 mg), and stearic acid (9.720 mg). Temozolomide capsules, USP, 250 mg: lactose anhydrous (182.5 mg), colloidal silicon dioxide (0.700 mg), sodium starch glycolate (22.50 mg), tartaric acid (9.000 mg), and stearic acid (13.50 mg). The body of the capsules for 5 mg, 20 mg, 140 mg, 180 mg and 250 mg strengths is made of gelatin, and titanium dioxide and is white opaque. The body of the capsules for 100 mg strengths is made of gelatin, titanium dioxide and ferric oxide yellow and is buff opaque. 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 shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and Black Iron Oxide. Temozolomide capsules, USP, 5 mg: The green opaque cap contains gelatin, titanium dioxide, FDA/E172 yellow iron oxide, and FD&C Blue #2. Temozolomide capsules, USP, 20 mg: The rich yellow opaque cap contains gelatin, titanium dioxide, and FDA/E172 yellow iron oxide. Temozolomide capsules, USP, 100 mg: The peach opaque cap contains gelatin, titanium dioxide, ferric oxide yellow, and ferric oxide red. Temozolomide capsules, USP, 140 mg: The blue opaque cap contains gelatin, titanium dioxide, and FD&C Blue#2. Temozolomide capsules, USP, 180 mg: The red opaque cap contains gelatin, titanium dioxide, and ferric oxide red. Temozolomide capsules, USP, 250 mg: The white opaque cap contains gelatin, and titanium dioxide. structure