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Merck

Paroxetine hydrochloride.

Profiles of drug substances, excipients, and related methodology (2013-05-15)
David Germann, George Ma, Feixue Han, Anna Tikhomirova
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Paroxetine hydrochloride (3S-trans)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-piperidine hydrochloride (or (-)-(3S,4R)-(4-(p-fluorophenyl)-3-[[3,4-(methylenedioxy)-phenoxy]methyl]piperidine hydrochloride), a phenylpiperidine derivative, is a selective serotonin reuptake inhibitor. Paroxetine is indicated for the treatment of depression, generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, and social anxiety disorder. The physicochemical properties, spectroscopic data (1D and 2D NMR, UV, FT-IR, MS, PXRD), stability, methods of preparation and chromatographic methods of analysis of pharmaceutical, and biological samples of paroxetine are documented in this review. Pharmacokinetics, metabolism, and pharmacological effects are also discussed.

MATERIALS
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Sigma-Aldrich
Paroxetine hydrochloride hemihydrate, ≥98% (HPLC), powder
Sigma-Aldrich
Paroxetine maleate salt, ≥98% (HPLC), solid
Paroxetine for system suitability, European Pharmacopoeia (EP) Reference Standard
Paroxetine hydrochloride hemihydrate, European Pharmacopoeia (EP) Reference Standard
Supelco
Paroxetine maleate solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material, Cerilliantยฎ