RT Journal Article SR Electronic T1 Resolving Liposomal Inhibition of Quantitative LAL Methods JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 260 OP 263 VO 53 IS 5 A1 L.G. Piluso A1 M.Y. Martinez YR 1999 UL http://journal.pda.org/content/53/5/260.abstract AB Bacterial endotoxin is composed of Lipid A as well as variable polysaccharide regions, and is capable of eliciting a pyrogenic response in vivo (1). NeXstar has developed a quantitative LAL assay at maximum sensitivity to provide assurance that its products are well below the endotoxin pyrogenic threshold. This test uses rigorous treatment of 1.0mL liposome samples with sodium dodecyl sulfate, an anionic surfactant, or CHAPS, a zwitterionic surfactant to disrupt the lipids present in the liposome sample including endotoxin. This liposome disruption allows potentially undetectable endotoxin to become available to the LAL cascade for quantification and overcomes inhibition of the LAL test by liposomes.