Development, validation and transfer into a factory environment of a liquid chromatography tandem mass spectrometry assay for the highly neurotoxic impurity FMTP (4-(4-fluorophenyl)-1-methyl-1,2,3,6-tetrahydropyridine) in paroxetine active pharmaceutical ingredient (API). [electronic resource]
- Journal of pharmaceutical and biomedical analysis Dec 2008
- 1082-9 p. digital
Publication Type: Journal Article
0731-7085
10.1016/j.jpba.2008.08.026 doi
Antidepressive Agents, Second-Generation--analysis Chemistry, Pharmaceutical--methods Chromatography, Liquid--methods Drug Contamination Drug Industry--methods Molecular Structure Neurotoxicity Syndromes--etiology Paroxetine--chemistry Pharmaceutical Preparations--analysis Pyridines--chemistry Reference Standards Reproducibility of Results Sensitivity and Specificity Tandem Mass Spectrometry--methods