Enhancement of an analytical method for the determination of squalene in anthrax vaccine adsorbed formulations.

Specific lots of anthrax vaccine adsorbed administered to members of the U.S. Armed Forces have been alleged to contain squalene, a chemical purported to be associated with illnesses of Gulf War veterans. A method of enhanced sensitivity for determining squalene in anthrax vaccine adsorbed using high-performance liquid chromatography with photodiode array detection has been developed, validated, and applied to 44 bottles of 38 lots of anthrax vaccine. In 43 bottles of 37 lots, no squalene was detected within a detection limit of 1ng/0.5ml dose (2 parts-per-billion). One lot, FAV008, was found to contain trace amounts of squalene at 7, 9, and 1microgl(-1), levels considerably below normal human plasma levels (290microgl(-1)). The overall results of this investigation provide direct evidence for the absence of squalene in nearly all of anthrax vaccine preparations tested.

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

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.

One-pot quantitative hydrolysis of lignocelluloses mediated by black liquor.

Black liquor from the kraft process facilitates quantitative biomass hydrolysis converting cellulose and hemicellulose into organic acids such as lactic acid (~50%), and lignin into small molecular aromatics, without gasification and black tar formation. Oxygen transfer between lignin and carbohydrates may be the mechanism. With this method, three tons of lignocellulosic biomass can potentially produce up to one ton of lactic acid, and one ton of small molecular aromatics. This novel usage of black liquor is environmentally viable because it is accompanied by significant emission reduction of particulates, sulfur and nitrogen oxides, most organic sulfur compounds and sulfites of black liquor were converted into sulfates.