Composition useful for treating e.g. depression, anxiety, obsessive-compulsive disorder, obesity comprises N-formyl paroxetine and a paroxetine compound

摘要

A composition comprises N-formyl paroxetine and a paroxetine compound (0-99.97 wt.%) (I). Independent claims are also included for: (1) preparation of (I) involving treating N-formyl paroxetine with a de-formylation agent (preferably organic or inorganic acid); (2) a compound 4-(4-fluoro-phenyl)-3-hydroxymethyl-pyridine-1-carbaldehyde (II); (3) determining (p2) the stability or purity of a paroxetine substance or composition (s1) involving assaying the paroxetine substance or (s1) for the presence of N-formyl paroxetine; and (4) assaying (p3) the quality of paroxetine involving forming a production lot of paroxetine pharmaceutical solid dosage forms (f1), where each dosage form comprises paroxetine or its salt and an excipient, removing a sample of (f1) from the production lot, assaying the sample for the presence and/or amount of N-formyl paroxetine and selling or releasing the production lot if the sample passes the assay with respect to the presence or amount of N-formyl paroxetine. ACTIVITY : Antidepressant; Tranquilizer; Anxiolytic; Anorectic; Antialcoholic. No biological data given. MECHANISM OF ACTION : Serotonin reuptake inhibitor.