According to James Cooper, no one disputes that low recovery of lipopolysaccharide (LPS), as used
for the LAL test control endotoxin, occurs in certain conditions, such as
chelating buffers and detergents. However, this issue does not affect all
products.
Furthermore, the issue at hand is low lipopolysaccharide recovery
rather than ‘low endotoxin’ recovery. Endotoxin is more sophisticated, being
composed of a hydrophilic polysaccharide covalently linked to a highly
conserved, hydrophobic lipid region. LPS and endotoxin do not behave in the
same way (LPS activity varies due to the presence of various salts and
detergents).
In addition, the use of a uniform screening test can reveal conditions of concern and legitimize the use of alternative naturally occurring endotoxin preparations for endotoxin challenge studies. However, to do required regulatory approval.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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