Table of Contents Author Guidelines Submit a Manuscript
International Journal of Analytical Chemistry
Volume 2009, Article ID 693210, 9 pages
Research Article

Chromatographic and Spectral Analysis of Two Main Extractable Compounds Present in Aqueous Extracts of Laminated Aluminum Foil Used for Protecting LDPE-Filled Drug Vials

1Department of Analytical Development, Dey L.P., 2751 Napa Valley Corporate Drive, Napa, CA 94558-6268, USA
2Department of Analytical Services, Teva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA 92618-1902, USA

Received 7 April 2009; Accepted 2 July 2009

Academic Editor: Peter L. Rinaldi

Copyright © 2009 Samuel O. Akapo et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. “Guidance for industry: container closure systems for packaging human drugs and biologics,” US FDA, Rockville, Md, USA,
  2. “Guideline on plastic immediate packaging materials,” European Medicine Agency (EMEA), London, UK,
  3. C. J. Taborsky, E. B. Sheinin, and D. G. Hunt, “A critical approach to the evaluation of packaging components and the regulatory and scientific considerations in developing a testing strategy,” American Pharmaceutical Review, vol. 9, no. 6, pp. 146–150, 2006. View at Google Scholar
  4. J. S. Kauffman, “Identification and risk-assessment of extractables and leachables,”
  5. V. S. Gaind and K. Jedrzejczak, “HPLC determination of rubber septum contaminants in the iodinated intravenous contrast agent (sodium iothalamate),” Journal of Analytical Toxicology, vol. 17, no. 1, pp. 34–37, 1993. View at Google Scholar
  6. “Guidance for industry: nasal spray and inhalation solution, suspension, and spray drug products—chemistry, manufacturing, and controls documentation,” US FDA, Rockville, Md, USA,
  7. F. Zhang, A. Chang, K. Karaisz, R. Feng, and J. Cai, “Structural identification of extractables from rubber closures used for pre-filled semisolid drug applicator by chromatography, mass spectrometry, and organic synthesis,” Journal of Pharmaceutical and Biomedical Analysis, vol. 34, no. 5, pp. 841–849, 2004. View at Google Scholar
  8. J. K. Baker, “Characterization of phthalate plasticizers by HPLC/thermospray mass spectrometry,” Journal of Pharmaceutical and Biomedical Analysis, vol. 15, no. 1, pp. 145–148, 1996. View at Publisher · View at Google Scholar
  9. D. R. Jenke, J. Story, and R. Lalani, “Extractables/leachables from plastic tubing used in product manufacturing,” International Journal of Pharmaceutics, vol. 315, no. 1-2, pp. 75–92, 2006. View at Publisher · View at Google Scholar
  10. D. L. Norwood, L. Nagao, S. Lyapustina, and M. Munos, “Application of modern analytical technologies to the identification of extractables and leachables,” American Pharmaceutical Review, vol. 8, no. 1, pp. 78–87, 2005. View at Google Scholar
  11. D. R. Jenke, J. M. Jene, M. Poss et al., “Accumulation of extractables in buffer solutions from a polyolefin plastic container,” International Journal of Pharmaceutics, vol. 297, no. 1-2, pp. 120–133, 2005. View at Publisher · View at Google Scholar
  12. P. R. Tiller, Z. El Fallah, V. Wilson et al., “Qualitative assessment of leachables using data-dependent liquid chromatography/mass spectrometry and liquid chromatography/tandem mass spectrometry,” Rapid Communications in Mass Spectrometry, vol. 11, no. 14, pp. 1570–1573, 1997. View at Publisher · View at Google Scholar
  13. H. Kim-Kang and S. G. Gilbert, “Isolation and identification of potential migrants in gamma-irradiated plastic laminates by using GC/MS and GC/IR,” Applied Spectroscopy, vol. 45, no. 4, pp. 521–714, 1991. View at Google Scholar
  14. S. O. Akapo and C. M. McCrea, “SPME-GC determination of potential volatile organic leachables in aqueous-based pharmaceutical formulations packaged in overwrapped LDPE vials,” Journal of Pharmaceutical and Biomedical Analysis, vol. 47, no. 3, pp. 526–534, 2008. View at Publisher · View at Google Scholar
  15. “Method validation report of HPLC limit test for potential leachables from foil laminate overwrap,” Analytical Test Report, Dey L.P., Napa CA., USA.
  16. “Guidance for industry: Q3B(R2): impurities in new drug products,” US FDA, Rockville, Md, USA,