This document describes a protocol for a quantitative detection of Gram negative bacterial
endotoxin in nanoparticle preparations using an end-point Limulus Amebocyte Lysate (LAL)
assay. The protocol is based on the QCL-1000 kit manufactured by BioWhittaker/Cambrex
Corporation(1)and the USP standard 85 “Bacterial endotoxin test”(2).