Control and analysis of alkyl esters of alkyl and aryl sulfonic acids in novel active pharmaceutical ingredients (APIs)

Journal of Pharmaceutical and Biomedical Analysis

Volumn 46, Issue 1, 2008, Pages 1-8

  Elder, D P ^a   Teasdale, A ^b   Lipczynski, A M ^c  

^a GLAXOSMITHKLINE   (United Kingdom)

^b ASTRAZENECA   (United Kingdom)

^c PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

Analysis; Regulatory guidelines; Sulfonate esters

Indexed keywords

ALKYL GROUP; ION; POLYCYCLIC AROMATIC HYDROCARBON DERIVATIVE; REAGENT; SODIUM CHLORIDE; SULFATE; SULFONIC ACID DERIVATIVE;

CATALYST; CHEMICAL ANALYSIS; COMPARATIVE STUDY; COST BENEFIT ANALYSIS; DERIVATIZATION; DRUG DETERMINATION; DRUG IMPURITY; DRUG INDUSTRY; DRUG ISOLATION; DRUG SYNTHESIS; GAS CHROMATOGRAPHY; GENOTOXICITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIQUID LIQUID EXTRACTION; MASS SPECTROMETRY; METHODOLOGY; PRIORITY JOURNAL; REVIEW; SOLID PHASE EXTRACTION; SOLVENT EXTRACTION; ULTRAVIOLET RADIATION;

ALKANESULFONATES; ARYLSULFONATES; CHEMISTRY, ANALYTICAL; CHROMATOGRAPHY, GAS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG INDUSTRY; MASS SPECTROMETRY; MOLECULAR STRUCTURE; PHARMACEUTICAL PREPARATIONS;

EID: 36849014367     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2007.10.013     Document Type: Review

References (21)

1. Council of Europe. 2000. Enquiry: alkyl mesilate (methanesulphonate) impurities in mesilate salts. Pharmeuropa. 12, 27.
2. European Pharmacopoeia, Dihydroergocristine Mesilate monograph, Ph. Eur. 5.0 (2005) 1437-1439.
3. ICH Q9, Quality Risk Management, June 2006, http://www.ICH.org/.
4. ICH Q8, Pharmaceutical Development, May 2006, http://www.ICH.org/.
5. United States Pharmacopeia, Atracurium Besylate monograph, USP 29 (2006) 216-217.
6. Guideline on the Limits of Genotoxic Impurities, Committee for Medicinal Products (CHMP), European Medicines Agency, London, 28 June 2006. (CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006).
7. ICH Q3A (R), Impurities in New Drug Substances, February 2002, http://www.ICH.org/.
8. ICH Q3B (R2), Impurities in New Drug Products, July 2006, http://www.ICH.org/.
9. Kroes R., Renwick A.G., Cheeseman M., Kleiner J., Mangelsdorf I., Piersma A., Schilter B., Sclatter J., van Schothorst F., Vos J.G., and Wurtzen G. Food Chem. Toxicol. 42 (2004) 65-83
10. Muller L., Mauthe R.J., Riley C.M., Andino M.M., de Antonis D., Beels C., DeGeorge J., De Knaep A.G.M., Ellison D., Fagerland J.A., Frank R., Fritschel B., Galloway S., Harpur E., Humfrey C.D.N., Jacks A.S., Jagota N., Mackinnon J., Mohan G., Ness D.K., O'Donovan M.R., Smith M.D., Vudathala G., and Yotti L. Reg. Toxicol. Pharm. 44 (2006) 198-211
11. ICH Q3C, Impurities: Guidelines for Residual Solvents, July 1997, http://www.ICH.org/.
12. Dobo K.L., Greene N., Cyr M.O., Caron S., and Ku W.W. Reg. Toxicol. Pharm. 44 (2006) 282-293
13. Miller S.A., Ju J., Cucolo M., Dai J.Y., Jia J., Narra K., Smith A.M., and Aubrey A.-F. Poster at the 52nd ASMS Conference (2004)
14. Snoddin D.J. Reg. Toxicol. Pharm. 45 (2006) 79-90
15. Filby W.G., Gunther K., and Penzhorn R.-D. Anal. Chem. 47 (1975) 2283-2285
16. Ramjit H.G., Singh M.M., and Coddington A.B. J. Mass Spectrom. 31 (1996) 867-872
17. Li W. J. Chromatogr. A 1046 (2004) 297-301
18. Colon I., and Richoll S.M. J. Pharm. Biomed. Anal. 39 (2005) 477-485
19. Taylor G.E., Gosling M., and Pearce A. J. Chromatgr. A 1119 (2006) 231-237
20. Lee C.R., Guivarch F., Van Dau C.N., Tessier D., and Krstulovic A.M. Analyst 128 (2003) 857-863
21. Alzaga R., Ryan R.W., Taylor-Worth K., Lipczynski A.M., Szucs R., and Sandra P. J. Pharm. Biomed Anal. 45 (2007) 472-479