Analytical methods for residual solvents determination in pharmaceutical products

Acta Poloniae Pharmaceutica - Drug Research

Volumn 67, Issue 1, 2010, Pages 13-26

  Grodowska, Katarzyna ^a,b   Parczewski, Andrzej ^a  

^a JAGIELLONIAN UNIVERSITY   (Poland)

^b PLIVA Krakow Pharmaceutical Company   (Poland)

Author keywords

Analytical methods; Gas chromatography; Headspace; Residual solvents; Single drop microextraction; Solid phase microextraction

Indexed keywords

SOLVENT;

ANALYTIC METHOD; CONTROLLED STUDY; DIFFERENTIAL SCANNING CALORIMETRY; DRUG DETERMINATION; DRUG IMPURITY; DRUG MANUFACTURE; DRUG SPECIFICITY; DRUG SYNTHESIS; GAS CHROMATOGRAPHY; MEDICAL LITERATURE; REVIEW; SOLID PHASE MICROEXTRACTION; THERMOGRAVIMETRY;

CHEMISTRY TECHNIQUES, ANALYTICAL; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, GAS; CONSUMER PRODUCT SAFETY; DRUG CONTAMINATION; DRUG INDUSTRY; GUIDELINES AS TOPIC; HUMANS; ORGANIC CHEMICALS; QUALITY CONTROL; SOLID PHASE MICROEXTRACTION; SOLVENTS; TECHNOLOGY, PHARMACEUTICAL;

EID: 76749103943     PISSN: 00016837     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (49)

1. Bauer M., Barthélémy C.: Handbook of solvents, Wypych G. Ed., 1st edn., p. 1129, ChemTec Publishing, Toronto, New York 2001.
2. http://www.pharmaquality.com/LabNotebook8. htm
3. Hymer C.: Pharm. Res. 20, 337 (2003).
4. XXXI USP, 〈467〉 General Chapter, Organic Volatile Impurities.
5. th Edition , 2.4.24. Identification and control of residual solvents.
6. Chen T. K., Phillips J. G., Durr W.: J. Chromatogr. A 811, 145 (1988).
7. A technical guide for static headspace analysis using GC. http://restekcorp.us/restek/images/ external/59895A.pdf
8. Grob K., Grob G.: High Resol. Chromatogr. Chromatogr. Commun. 2, 15 (1979).
9. http://www.kinesis-solutions.co.uk/kinesis -techtips.asp?id=11
10. Materials from the course: "Practical aspects of gas chromatography", Analytical Chemistry Faculty, Chemistry Department, Politechnika Gdańska, 02-06.07. 2007 Gdańsk.
11. ww.gerstelus.com/admin/prod-file.php?path= 'ramana'&file=GC- Injection-Primer.pdf
12. http://www.restek.us/restek/images/external/ 59895A.pdf
13. Wenzl T., Lankmayr E. P.: Anal. Bioanal. Chem. 372, 649 (2002).
14. McAuliffe C.: Chem. Technol. 1, 46 (1971).
15. Suzuki M., Tsuge S., Takeuchi T.: Anal. Chem. 42, 1705 (1970).
16. Kolb B., Pospisil P.: Chromatographia 10, 705 (1977).
17. Camarasu C. C., Meqei - Szuts M., Varga. G. B.: J. Pharm. Biomed. Anal. 18, 623 (1998).
18. Arthur C. L., Pawliszyn J.: Anal. Chem. 62, 2145 (1990).
19. Legrand S., Dugay J., Vial J.: J. Chromatogr. A. 999, 195 (2003).
20. Coran S. A., Giannellini V., Furlanetto S., Bambagiotti - Alberti. M., Pinzauti S.: J. Chromatogr. A. 915, 209 (2001).
21. Lord H., Pawliszyn J.: J. Chromatogr. A. 885, 153 (2000).
22. Lakatos M.: J. Pharm. Biomed. Anal. 47, 954 (2008).
23. Michulec M., Wardencki W.: Chromatographia 64, 191 (2006).
24. Nazarenko A. Y.: American Laboratory (August), 30 (2004).
25. Wood D. C., Miller J. M., Christ I.: LCGC North America 22, 516 (2004).
26. Michulec M., Wardencki W.: Chromatographia 60, 273 (2004).
27. http://www.chem.agilent.com/cag/cabu/capgccols.htm
28. http://www.chromatography-online.org/topics/ capillary/column.html
29. nd edn., p. 80, Academic Press, San Diego 1987.
30. Rocheleau M-J., Titley M., Bolduc J.: J. Chromatogr. B 805, 77 (2004).
31. st edn. p. 207, CRC Press, Boca Raton 2001.
32. Schmitt V. O., Pereiro I. R., Łobiński R.: Anal. Commun. 34, 141 (1997).
33. Veriotti T., Sacks R.: Anal. Chem. 73, 4395 (2001).
34. http://www.pg.gda.pl/chem/CEEAM/Dokumenty/ CEEAM-ksiazka/Chapters/ chapter6.pdf
35. Gorecki T., Harynuk J., Panić O.: J. Sep. Sci. 27, 359 (2004).
36. Wittrig R. E., Dorman F. L., English C. M., Sacks R. D.: J. Chromatogr. A1027, 75 (2004).
37. Scott R. P. W.: Gas chromatography, p. 45, Chrom-Ed Book Series.
38. Westmorland D. G., Rhodes G. R.: Pure Appl. Chem. 61, 1148 (1989).
39. Fialkov A. B., Steiner U., Lehotav S. J., Amirav A.: Int. J. Mass Spectrom. 260, 31 (2007).
40. Witschi C., Doelker E.: Eur. J. Pharm. Biopharm. 43, 215 (1997).
41. ttp://www.ssi.shimadzu.com/products/detspecs.cfm
42. st edn., p.1133, ChemTec Publishing, Toronto - New York 2001
43. Benoit J. P., Courteille F., Thies C.: Int. J. Pharm. 29, 95 (1986).
44. Dubernet C., Rouland J. C., Benoit J. P.: Int. J. Pharm. 64, 99 (1990).
45. List P. H., Laun G.: Pharm. Ind. 42, 399 (1980).
46. Weitkamp H., Barth R.: Bestimmung kleiner Gehaltswerte nach dem Aufstockverfahren. Einfurungin die quantitative Infrarot-Spektrophotometrie, Weitkamp H., Barth R. Eds., p. 58, Georg Thieme Verlag, Stuttgart 1976.
47. Osawa Z., Aiba M.: Polymer Photochem. 2, 339 (1982).
48. Thomasin C., Johansen P., Adler R., et al.: Eur. J. Pharm. Biopharm. 42, 16 (1996).
49. Avdovich H. W., Lebelle M. J., Savard C., Wilson W. L.: Forensic Sci. Int. 49, 225 (1991).