title: Bupropion Hydrochloride.
abstract: Bupropion hydrochloride is a norepinephrine-dopamine disinhibitor (NDDI) approved for the treatment of depression and smoking cessation. Bupropion is a trimethylated monocyclic phenylaminoketone second-generation antidepressant, which differs structurally from most antidepressants, and resides in a novel mechanistic class that has no direct action on the serotonin system. Comprehensive chemical, physical, and spectroscopic profiles are presented. This analytical profile provides an extensive spectroscopic investigation utilizing mass spectrometry, one- and two-dimensional NMR, solid-state NMR, IR, NIR, Raman, UV, and X-ray diffraction. The profile also includes significant wet chemistry studies for pH, solubility, solution, and plasma stability. Both HPLC and UPLC methodology are presented for bupropion and its related impurities or major metabolites. The profile concludes with an overview of biological properties that includes toxicity, drug metabolism, and pharmacokinetics.
authors.affiliation: Division of Product Quality Research, US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Testing and Research, Silver Spring, MD, United States.
authors.forename: S R
authors.initials: SR
authors.lastname: Khan
authors.affiliation: Division of Product Quality Research, US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Testing and Research, Silver Spring, MD, United States.
authors.forename: R T
authors.initials: RT
authors.lastname: Berendt
authors.affiliation: Division of Product Quality Research, US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Testing and Research, Silver Spring, MD, United States.
authors.forename: C D
authors.initials: CD
authors.lastname: Ellison
authors.affiliation: Division of Product Quality Research, US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Testing and Research, Silver Spring, MD, United States.
authors.forename: A B
authors.initials: AB
authors.lastname: Ciavarella
authors.affiliation: Division of Product Quality Research, US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Testing and Research, Silver Spring, MD, United States.
authors.forename: E
authors.initials: E
authors.lastname: Asafu-Adjaye
authors.affiliation: Rangel College of Pharmacy, College Station, TX, United States.
authors.forename: M A
authors.initials: MA
authors.lastname: Khan
authors.affiliation: Division of Product Quality Research, US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Testing and Research, Silver Spring, MD, United States.
authors.forename: P J
authors.initials: PJ
authors.lastname: Faustino
mesh_terms: D000818:Animals; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics / Q000627:therapeutic use; D016642:Bupropion / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics / Q000627:therapeutic use; D002626:Chemistry, Pharmaceutical; D006801:Humans
chemical_list: D018687:Antidepressive Agents, Second-Generation; D016642:Bupropion
keywords: Aminoketone; Antidepressant; Bupropion hydrochloride; Norepinephrine-dopamine disinhibitor and stability