SPL Set ID: 9d2c209b-248e-4e26-9cde-fe0abe4428c1

Bupropion hydrochloride USP is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-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, crystalline, and highly soluble in water. 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 (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, hydroxy propyl methyl cellulose, diluted hydrochloric acid, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, the 100 mg-tablet contains FD&C Blue No. 1 Aluminum lake, the 150 mg- tablet contains FD&C Blue No. 2 Aluminum lake and FD&C Red No. 40 Aluminum lake and the 200 mg-tablet contains FD&C Red No. 40 Aluminum lake. FDA approved dissolution specification differs from the USP. Chemical Structure