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Paroxetine hydrochloride.

Profiles of drug substances, excipients, and related methodology (2013-05-15)
David Germann, George Ma, Feixue Han, Anna Tikhomirova
ABSTRACT

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
Product Number
Brand
Product Description

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