Measurement of residual solvents in a drug substance by a purge-and-trap method

Journal of Pharmaceutical and Biomedical Analysis

Volumn 47, Issue 4-5, 2008, Pages 954-957

  Lakatos, Miklós ^a  

^a BUDAPEST UNIVERSITY OF TECHNOLOGY AND ECONOMICS   (Hungary)

Author keywords

Class1 solvents; Drug; P T GC FID; Purge and trap; Residual solvents

Indexed keywords

1,2 DICHLOROETHYLENE; BENZENE; CARBON TETRACHLORIDE; SOLVENT; VINYLIDENE CHLORIDE;

ANALYTIC METHOD; ARTICLE; EXTRACTION; GAS CHROMATOGRAPHY; INTERMETHOD COMPARISON; PRIORITY JOURNAL; PURGE AND TRAP GAS EXTRACTION;

BENZENE; CARBON TETRACHLORIDE; CHROMATOGRAPHY, GAS; DRUG CONTAMINATION; ETHYL CHLORIDE; FLAME IONIZATION; FORMAMIDES; METHYLENE CHLORIDE; NITROGEN; PHARMACEUTICAL PREPARATIONS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; SENSITIVITY AND SPECIFICITY; SOFTWARE; SOLVENTS; TEMPERATURE; WATER;

EID: 44749085199     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2008.03.009     Document Type: Article

References (24)

1. Proceedings of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Tripartite harmonised guideline Q3C Impurities, Residual Solvents, 1997.
2. Residual Solvents (5.4), European Pharmacopoeia, Supplement 4.6, Directorate for the Quality of Medicines of the Council of Europe, Strasbourg, 4th ed., 2004, p. 3911.
3. Witschi C., and Doelker E. Eur. J. Pharm. Biopharm. 43 (1997) 215-242
4. Camarasu C., Madichie C., and Williams R. TrAC, Trends Anal. Chem. 25 (2006) 768-777
5. Pérez Pavón J.L., del Nogal Sánchez M., Fernández Laespada M.E., García Pinto C., and Cordero B.M. J. Chromatogr. A 1141 (2007) 123-130
6. Wahlroos O. Ann. Acad. Sci. Fennicae, Ser. All. Chem. 122 (1963) 1
7. Grob K. J. Chromatogr. A 84 (1973) 255-273
8. Drozd J., and Novák J. J. Chromatogr. A 165 (1979) 141-165
9. Curvers J., Noy Th., Cramers C., and Rijks J. J. Chromatogr. A 289 (1984) 171-182
10. Nunez A.J., González L.F., and Janák J. J. Chromatogr. A 300 (1984) 127-162
11. Vitenberg A.G. J. Chromatogr. A 556 (1991) 1-24
12. Vitenberg A.G., and Ioffe B.V. J. Chromatogr. A 471 (1989) 55-60
13. Mulligan K.J., Brueggemeyer T.W., Crockett D.F., and Schepman J.B. J. Chromatogr. B 686 (1996) 85-95
14. Snow N.H., and Slack G.C. TrAC, Trends Anal. Chem. 21 (2002) 608-617
15. Kolb B. J. Chromatogr. A 842 (1999) 163-205
16. Ketola R.A., Virkki V.T., Ojala M., Komppa V., and Kotiaho T. Talanta 44 (1997) 373-382
17. Kállai M., and Balla J. Chromatographia 56 (2002) 357-360
18. International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Q2B: Validation of Analytical Procedures: Methodology, Step 4, November 1996.
19. Fliszar K., Wiggins J.M., Pignoli C.M., Martin G.P., and Li Z. J. Chromatogr. A 1027 (2004) 83-91
20. Michulec M., and Wardencki W. J. Chromatogr. A 1071 (2005) 119-124
21. Westmorland D.G., and Rhodes G.R. Pure Appl. Chem. 61 (1989) 1147-1160
22. Pérez Pavón J.L., del Nogal Sánchez M., García Pinto C., Fernández Laespada M.E., and Moreno Cordero B. Anal. Chem. 78 (2006) 4901-4908
23. Ying Liu, and Chang-Qin Hua. Anal. Chim. Acta 575 (2006) 246-254
24. Camarasu C.C., Mezei-Szu{combining double acute accent}ts M., and Bertók Varga G. J. Pharm. Biomed. Anal. 18 (1998) 623-638