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)

Journal of Pharmaceutical and Biomedical Analysis

Volumn 48, Issue 4, 2008, Pages 1082-1089

  Borman, Phil J ^b   Chatfield, Marion J ^b   Crowley, Elizabeth L ^a   Eckers, Christine ^b   Elder, David P ^b   Francey, Scott W ^b   Laures, Alice M F ^b   Wolff, Jean Claude ^b  

^a GLAXOSMITHKLINE   (Ireland)

^b GLAXOSMITHKLINE   (United Kingdom)

Author keywords

LC MS MS assay; Neurotoxin; Paroxetine; Sub ppm impurity; Technology transfer to factory

Indexed keywords

4 (4 FLUOROPHENYL) 1,2,3,6 TETRAHYDRO 1 METHYLPYRIDINE; PAROXETINE; PYRIDINE DERIVATIVE; UNCLASSIFIED DRUG;

ACCURACY; ARTICLE; DRUG IMPURITY; DRUG MANUFACTURE; LIQUID CHROMATOGRAPHY; LIQUID CHROMATOGRAPHY TANDEM MASS SPECTROMETRY; NEUROTOXICITY; PRIORITY JOURNAL; QUALITY CONTROL; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; TANDEM MASS SPECTROMETRY;

ANTIDEPRESSIVE AGENTS, SECOND-GENERATION; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, LIQUID; DRUG CONTAMINATION; DRUG INDUSTRY; MOLECULAR STRUCTURE; NEUROTOXICITY SYNDROMES; PAROXETINE; PHARMACEUTICAL PREPARATIONS; PYRIDINES; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; TANDEM MASS SPECTROMETRY;

EID: 57849120055     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2008.08.026     Document Type: Article

References (16)

1. ICH Q3A (R), Impurities in New Drug Substances, February 2002, http://www.ICH.org/.
2. ICH Q3B, Impurities in New Drug Products, February 2002, http://www.ICH.org/.
3. Guideline on the Limits of Genotoxic Impurities, Committee for Medicinal Products (CHMP), European Medicines Agency, London, June 28, 2006 (CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006).
4. Langston J.W., Ballard P., Tetrud J.W., and Irwin I. Science 219 (1983) 979-980
5. Youngster S.K., Sonsalia P.K., and Heikkila R.E. J. Neurochem. 48 (1987) 929-934
6. Heikkila R.E., Manzino L., Cabbat F.S., and Duvoisin R.C. J. Neurochem. 45 (1985) 1049-1054
7. Youngster S.K., Sonsalia P.K., Sieber B.A., and Heikkila R.E. J. Pharmacol. Exp. Ther. 249 (1989) 820-828
8. Kramer J., Caldwell J., Hoffmann A., Tempel P., and Weiner G. EMEA Pharmacovigilence 17 (1998) 283-299
9. Pethidine Hydrochloride Monograph, Supplement 6.3, Ph. Eur. 0420, 2008, pp. 2650-2651.
10. Farina A., Gostoli G., Bossu E., Montinaro A., Lestingi C., and Lecce R. J. Pharm. Biomed. Anal. 37 (2005) 1089-1093
11. J.A. Christensen, R.F. Squires, US Patent 4,007,196 (1977).
12. Willcocks K., Barnes R.D., Rustidge D.C., and Tide D.J.D. J. Label. Compd. Radiopharm. 33 (1993) 783-794
13. Paroxetine Hydrochloride Hemihydrate Monograph, Supplement 6.3, Ph. Eur. 2018, 2008, pp. 2619-2621.
14. Paroxetine Hydrochloride Anhydrate Monograph, Supplement 6.3, Ph. Eur. 2283, 2008, pp. 2616-2619.
15. ICH, Harmonised Tripartie Guide Prepared within the Third International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), Validation of Analytical Procedures: Methodology, 1996, pp. 1-8 http://www.ifpma.org/ich1.html.
16. The United States Pharmacopeia, 23rd edition, National Formulary 18, United States Pharmacopeial Convention, Rockville, USA, 1995.