Sunday, 30 August 2020

Modern myth #6: Low endotoxin recovery affects all products


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.

Reference: https://www.americanpharmaceuticalreview.com/Featured-Articles/181837-LER-Microbiology-s-Hottest-Urban-Myth/

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

No comments:

Post a comment

Pharmaceutical Microbiology Resources

Special offers