SPL Set ID: 681dfb5c-fc5c-427e-81f6-4b4e934978a2

Telmisartan and hydrochlorothiazide tablets USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT 1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H­-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its molecular formula is C 33 H 30 N 4 O 2 , its molecular weight is 514.63, and its structural formula is: Telmisartan USP is a white or slightly yellowish, crystalline powder. It is sparingly soluble in methylene chloride, slightly soluble in methanol, practically insoluble in water. It dissolves in 1M sodium hydroxide. Hydrochlorothiazide USP is white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7­-sulfonamide 1,1-dioxide. Its molecular formula is C 7 H 8 ClN 3 O 4 S 2 , and its structural formula is: Telmisartan and hydrochlorothiazide tablets USP are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, mannitol, meglumine, povidone, sodium hydroxide pellets and sodium stearyl fumarate. In addition, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain red ferric oxide and the 80 mg/25 mg tablets contain yellow ferric oxide. Telmisartan and hydrochlorothiazide tablets USP are hygroscopic and require protection from moisture. Meets USP dissolution test 3. Chemical Structure1 Chemical Structure2