Organic volatile impurities in pharmaceuticals

Indian Journal of Pharmaceutical Sciences

Volumn 69, Issue 3, 2007, Pages 352-359

  Puranik, S ^a   Pai, P N S ^a   Rao, G ^a  

^a AL AMEEN COLLEGE OF PHARMACY   (India)

Author keywords

Gas chromatography; Organic volatile impurities; Residual solvents

Indexed keywords

1,2 DICHLOROETHYLENE; ACETONITRILE; CHLOROBENZENE; CYCLOHEXANE; SOLVENT;

CARCINOGENIC ACTIVITY; CRYSTAL STRUCTURE; DRUG FORMULATION; DRUG MANUFACTURE; DRUG SYNTHESIS; ENVIRONMENTAL FACTOR; GAS CHROMATOGRAPHY; GENOTOXICITY; HEALTH HAZARD; MEDICAL LITERATURE; MEDICINAL PLANT; PRACTICE GUIDELINE; QUALITY CONTROL; REVIEW; THERMOGRAVIMETRY; TOXICOLOGY;

EID: 34548513327     PISSN: 0250474X     EISSN: None     Source Type: Journal    
DOI: 10.4103/0250-474X.34542     Document Type: Review

References (53)

1. International Conference on Harmonization, Impurities in new drug substances, 2002. Available from: http://www.ich.org.
2. Hymer CB. Residual solvent testing: A review of gas chromatographic and alternative techniques. Pharm Res 2003;23:337-44.
3. International Conference of Harmonization, Impurities in new drug substances, 1997. Available from: http://www.ich.org.
4. Haky JE, Stickney TM. Automated gas chromatographic method for the determination of residual solvents in bulk pharmaceuticals. J Chromatogr A 1985;321:137-44.
5. Organic volatile impurities. Pharm Forum 1988;14:3601-702.
6. United States Pharmacopeia, (USP-NF XXIV). Pharmacopoeial Convention Inc.: Rockville, Maryland, United States; 1995. p. 1877.
7. Karen MA, Handbook of Modern Pharmaceutical Analysis. Vol. III, Separations Science Technology, Academic Press: 2001. p. 86-95.
8. Camarasu CC. Head space SPME method development for the analysis of volatile polar residual solvents by GC-MS. J Pharm Biomed Anal 2000;23:197-210.
9. Osawa Z, Aiba M. Effect of residual solvent on photo degradation of Poly (vinyl chloride). Ploy Photochem 1982;2:339-48.
10. Li Z, Yieng HH, Gregory PM. Static headspace gas chromatographic analysis of the residual solvents in gel extrusion module tablet formulations. J Pharm Biomed Anal 2002;28:673-82.
11. Raquel O, Guillem C, Joan FD, José LF, Juan C. Static headspace gas chromatographic method for quantitative determination of residual solvents in pharmaceutical drug substances according to European Pharmacopoeia requirements. J Chrom A 2004;1057:193-201.
12. Raghani AR. High-speed gas chromatographic analysis of solvents in pharmaceuticals using solid phase microextraction. J Pharm Biomed Anal 2002;29:507-18.
13. Marie JR, Melanie, Julie B. Measuring residual solvents in pharmaceutical samples using fast gas chromatography techniques. J Chromatogr B 2004;805:77-86.
14. Weiyong Li. Trace analysis of residual methyl methanesulfonate, ethyl methanesulfonate and isopropyl methanesulfonate in pharmaceuticals by capillary gas chromatography with flame ionization detection. J Chrom A 2004;1046:297-301.
15. Legrand S, Dugay J, Vail J. Use of solid-phase microextraction coupled with gas chromatography for the determination of residual solvents in pharmaceuticals in pharmaceutical products. J Chrom A 2003;999:195-201.
16. Saprykin YA, Golovko B, Pazderski YA. Gas chromatographic analysis of volatile chlorides for organic and organochlorine impurities using a high-frequency emission detector. J Chrom A 2004;246:51-6.
17. Hercegova A, Domotorova M, Matisova E, Kirchner M, Otrekal R, Steluca V. Fast gas chromatography with solid phase extraction cleanup for ultratrace analysis of pesticide residues in baby food. J Chrom A 2005;1084:46-53.
18. Haky JE, Stickney TM. Automated gas chromatographic method for the determination of residual solvents in bulk pharmaceuticals. J Chromatogr A 1985;321:137-44.
19. Foust DW, Bergren MS. Analysis of solvent residues in pharmaceutical bulk drugs by wall-coated open tubular gas chromatography. J Chrom A 1989;469:161-73.
20. Chen TK, Moeckel W and Superhant HL. Modifications to the European Pharmacopeias proposal on residual solvents. Pharmeuropa 1992;4:62-7.
21. Rastogi SC. Gas chromatographic analysis of organic solvents mixtures on capillary columns of different polarity. Chromatographia 1993;37:211-4.
22. Deborah RW, Shila AH. Determination of impurities in "Yellow" Forase Pharm Sci 1984;73:115.
23. Kevin JM, Thomas WB. Analysis of organic volatile impurities as a forensic tool for the examination of bulk pharmaceuticals. J Chromatogr Biomed Appl 1996;686:85-95.
24. Clayton B, Hymer. Static headspace gas chromatographic method for the determination of residual solvents in vigabatrin drug substance. J Chrom A 1988;438:103-7.
25. Hong L, Attorfer H. A micro-sized technique for determination of organic volatile impurities in water-insoluble pharmaceuticals. Chromatograpia 2001;53:76-80.
26. Dennis KJ, Josephs PA. Proposed automated headspace method for organic volatile impurities (467) and other residual solvents. Pharm Forum 1992;18:2964-72.
27. Naughton VJ. A Micro-sized headspace GC technique for determination of organic volatile impurities in water - insoluble pharmaceuticals. Pharm Forum 1994;39:645.
28. Muligan KJ, McCauley H. Factors that influence the determination of residual solvents in pharmaceuticals by automated static headspace sampling coupled to capillary GC-MS. J Chromatogr Sci 1995;33:49.
29. Witschi C, Dweller E. Residual solvents in pharmaceuticals products: Acceptable limits inß uences of physicochemical properties, analytical methods and documented values. Eur J Pharm Biopharm 1997;43:215-42.
30. Narendra Kumar, John C, Egoville. Headspace gas chromatography method for the analysis of volatile impurities in a hormone replacement transdermal patch. J Chrom A 1999;859:113-8.
31. th ed. New Delhi; CBS Publishers and Distributors: 1986. p. 540.
32. Leonard CB. Remington the sciences and Practice of Pharmacy. Vol-1, Easton, PA; MAC Publishing Company: 1995. 52, p. 542.
33. Costin C, Camarasu. Head space SPME method development for the analysis of volatile polar residual solvents by GC-MS. J Pharm Biomed Anal 2000;23:197-210.
34. European pharmacopoeia, Directorate for the quality of medicines of the council of Europe, 4th ed. Strasboug, France; 2002.
35. Marinicher AN, Vilenberg AG, Bureiok AS. Efficiency of gas extraction in headspace analysis. J Chrom A 1992;600:251-6.
36. United States Pharmacopeia (USP-NF XXIV). Harmacopoeial Convention Inc.: Rockville, Maryland, United States; 1995. p. 1877.
37. Zhang Z, Pawliszyn J. Sampling volatile organic compounds using a modified solid phase microextraction device. J High Resol Chromatogr 1996;19:155-60.
38. Shirey R. Unknown residual solvents identification in drug products by headspace solid phase microextraction gas chromatography-mass spectrometry. J High Resol Chromatogr 1995;18:495-9.
39. Martos PA, Pawliszyn J. Calibration of soidphase microextration for air analysis based on physical chemical properties of the coating. Anal Chem 1997;69:206-15.
40. Pan L, Pawdeszyn J. Derivatization- solid phase microextraction: A new approach. Anal Chem 1997;69:196-203.
41. Gorecki T, Pawliszyn J. Solid phase microextraction /isothermal GC for rapid analysis of complex organic samples. J High Resol Chromatogr 1995;18:161-6.
42. Morcillo Y, Cai Y, Bayona JM. Rapid determination of methylene compounds in aqueous samples using solid phase microextraction and capillary gas chromatography following in-situ derivation with sodium tetraethylborate. J High Resol Chromatogr 1995;18:776.
43. Grote C, Pawliszyn. Unknown residual solvents identification in drug products by headspace solid phase microextraction gas chromatographymass spectrometry. J Anal Chem 1997;69:587-98.
44. Moens L, Smaelel TD, Dams R, Broede PV, Sandra P. Sensitive, Simultaneous determination of organomercury, lead, and tin compounds with solid phase microextraction capillary gas chromatography combined with inductively coupled plasma mass spectrometry. Anal Chem 1997;69:1604-11.
45. Lkso H, Ng WF. Determination of chemical warfare agents in natural water samples by soild-phase microextraction. Anal Chem 1997;69:1866-72.
46. Fromberg A, Nilsson T, Larsen BR, Montanarella L, Facchetti S, Madsen JO. Analysis of chloro and nitroanilines and benzenes in soils by headspace solid-phase microextraction. J Chromatogr 1996;746:71-81.
47. Page B, Lacroix G. Unknown residual solvents identification in drug products by headspace solid phase microextraction gas chromatographymass spectrometry. J Cromatogr 1993;648:199-211.
48. Camarasu C, Mezel M, Szobo A. Headspace solid phase microextraction method optimization for residual solvent analysis. Acta Pharm Hung 1999;69:77-84.
49. Camarasu CC, Mezel SM, Varga GB. Residual solvents in pharmaceutical products by GC-HS and GC-MS-SPME. J Pharm Biomed Anal 1998;18:623-38.
50. Koji U, Atsuya H, Kazuichi U, Masayuki G. Matrix media selection for the determination of residual solvents in pharmaceuticals by static headspace gas chromatography. J Chrom A 2004;1057:203-10.
51. Derrick CW, James MM, Ingo C. Headspace liquid microextraction. LCGC North Am 2004;22:516-22.
52. Wallace B, Kancler J. One universal method for residual solvents in pharmaceuticals using a high temperature static headspace sample introduction. System application note 7000-021b.doc, Teledyne Tekmar Instruments: Feb 2004.
53. Wittrig RE, Dorman FL, English CM, Sachs RD. High speed analysis of residual solvents by flow-modulation gas chromatography. J Chrom A 2004;1027:75-82.