SPL Set ID: f39a2a7a-7a7e-4dd8-9704-54d9598504fb

Paroxetine extended-release tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans -4 R -(4'-fluorophenyl)-3 S -[(3',4'methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19 H 20 FNO 3 ∙HCl∙1/2H 2 O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride is: Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120°C to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine extended-release tablets, USP are intended for oral administration. Each extended-release tablet contains 12.5 mg, 25 mg, or 37.5 mg paroxetine equivalent to 14.25 mg, 28.51 mg, or 42.76 mg of paroxetine hydrochloride, respectively. One layer of the tablet consists of a degradable barrier layer and the other contains the active material in a hydrophilic matrix. Inactive ingredients consist of colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, ferric oxide yellow (12.5mg, 25 mg and 37.5 mg), glyceryl dibehenate, D&C Yellow No. 10 aluminum lake (12.5 mg), FD&C Blue No. 2 aluminum lake (12.5 mg and 37.5 mg), FD&C Red No. 40 aluminum lake (12.5 mg), FD&C Yellow No. 6 aluminum lake (12.5 mg), ferric oxide red (25 mg), ferrosoferric oxide (25 mg), methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. FDA approved dissolution test specifications differ from USP. Chemical Structure