SPL Set ID: e6527adf-8c74-4d81-9199-d56a7fca895e

Benazepril hydrochloride USP is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H -1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is Its empirical formula is C 24 H 28 N 2 O 5 ·HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Hydrochlorothiazide USP is a white or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide’s chemical name is 6-chloro-3,4-dihydro-2 H -1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 , and its molecular weight is 297.73. Hydrochlorothiazide is a thiazide diuretic. Benazepril Hydrochloride and Hydrochlorothiazide Tablets USP are a combination of benazepril hydrochloride USP and hydrochlorothiazide USP. The tablets are formulated for oral administration with a combination of 5, 10 or 20 mg of benazepril hydrochloride USP and 6.25, 12.5 or 25 mg of hydrochlorothiazide USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide and triacetin. The 10 mg/12.5 mg tablets also contain FD&C Blue #2 and iron oxide red. The 20 mg/12.5 mg tablets also contain FD&C Red #40 and FD&C Yellow #6. The 20 mg/25 mg tablets also contain FD&C Blue #2 and FD&C Red #40. Benazepril Hydrochloride and Hydrochlorothiazide Tablets USP meet USP Dissolution Test 2. Benazepril-structure.jpg Hydrochlorothiazide-structure.jpg