Method selection for trace analysis of genotoxic impurities in pharmaceuticals

LC GC Europe

Volumn 22, Issue 12, 2009, Pages

  David, Frank ^a   Vanhoenacker, Gerd ^b   Sandra, Pat ^a   Jacq, Karine ^b   Baker, Andrew ^c  

^a GHENT UNIVERSITY   (Belgium)

^b RIC   (Belgium)

^c ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 77951810707     PISSN: 14716577     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (12)

1. T. McGovern et al., Trends in Analytical Chemistry, 25 (8), 790 (2006).
2. L. Muller et al., Toxicol. Pharmacol., 44, 198 (2006).
3. European Medicines Evaluation Agency, Committee for Medicinal Products for Human Use, Guideline on the limits of genotoxic impurities, CPMP/SWP/5199/02, London, 28 June 2006 (http://www.emea.europa.eu/pdfs/human /swp/519902en. pdf|-http://www.emea.europa.eu/pdfs/human/swp/519902en. pdf [http://www.emea.europa.eu /pdfs/human/swp/519902en. pdf|-http://www.emea. europa.eu/pdfs/human/swp/519902en. pdf%0a%09%09%09%09])
4. Guidance for Industry. Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches. US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research (CDER), December 2008.
5. Information on structural alert functionalities can be found at: http://ecb.jrc.ec.europa.eu/documents /QSAR/EUR-23844-EN.pdf|-http://ecb.jrc.ec. europa.eu/documents/QSAR/EUR-23844-EN.pdf [http://ecb.jrc.ec.europa.eu/ documents/qsar/eur-23844-en. pdf|-http://ecb.jrc.ec.europa.eu/documents /qsar/eur-23844-en. pdf%0a%09%09%09%09].
6. D. P. Elder, A. M. Lipczynski and A. Teasdale, J. Pharm. Biomed. Anal., 48, 497 (2008).
7. DHS brochure Gerstel GmbH, http://www.gerstel.com/en/dynamic-headspace. htm|-http://www.gerstel.com /en/dynamic-headspace.htm [http://www.gerstel.com/ en/dynamic-headspace.htm|-http://www.gerstel.com/en/dynamicheadspace. htm%0a%09%09%09%09]
8. D. P. Elder, A. Teasdale and A. M. Lipczynski, J. Pharm. Biomed. Anal., 46, 1 (2008).
9. R. Alzaga et al., J. Pharm. Biomed. Anal., 45, 472 (2007).
10. K. Jacq et al., J. Pharm. Biomed. Anal., 48, 1339 (2008).
11. F. David et al., Anal. Bioanal. Chem., 2009, submitted.
12. G. Vanhoenacker et al., J. Chrom. A, 1216, 3563 (2009).