SPL Set ID: c0d92aa1-638d-44dd-a7f1-26bdbb1176ef

Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13 H 18 ClNO•HCl. Bupropion hydrochloride powder is white and soluble in water, in 0.1 N Hydrochloric acid and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg which are pink round biconvex coated tablets imprinted with '188' in black ink on one side and plain on other side and 300 mg which are pink, round biconvex coated tablets imprinted with '189' in black ink on one side and plain on the other side. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opacode ® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), opadry ® pink (it contains hypromellose, titanium dioxide, triacetin, talc, iron oxide red), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14. Image