Development and application of an analytical method for the determination of squalene in formulations of anthrax vaccine adsorbed.

Abstract

Specific lots of Anthrax Vaccine Adsorbed, administered to members of the US Armed Forces, have been described on various Internet sites and in news articles as a source of squalene, a chemical purported by these media to be associated with the Gulf War Syndrome. We have developed and validated a method using high-performance liquid chromatography with ultraviolet detection for the determination of squalene in anthrax vaccine preparations. The method has a limit of detection of 140 parts per billion and has been successfully applied to a commercial vaccine known to contain squalene. We have applied this method to 17 lots of Anthrax Vaccine Adsorbed administered to members of the US Armed Forces. No squalene has been detected in any lot. The results of these analyses provide direct evidence for the absence of squalene as an ingredient or a manufacturing contaminant in Anthrax Vaccine Adsorbed.

• Authors: Ronald J Spanggord, Benjamin Wu, Meg Sun, Peter Lim, William Y Ellis
• Journal: Journal of pharmaceutical and biomedical analysis (J Pharm Biomed Anal) Vol. 29 Issue 1-2 Pg. 183-93 (Jun 20 2002) ISSN: 0731-7085 [Print] England
• PMID: 12062677 (Publication Type: Journal Article, Research Support, U.S. Gov't, Non-P.H.S.)

Chemical References

• Anthrax Vaccines
• Squalene

Topics

• Anthrax Vaccines (analysis)
• Chromatography, High Pressure Liquid (methods)
• Drug Contamination
• Drug Stability
• Humans
• Persian Gulf Syndrome (chemically induced)
• Reference Standards
• Squalene (adverse effects, analysis)