This document discusses the quantitative detection of Gram negative bacterial endotoxin in
nanoparticle preparations using the gel-clot Limulus Amebocyte Lysate (LAL). The protocolfor
this assay is based on instructions provided withthe reagents from Associates of Cape Code as well as the USP standard 85 “Bacterial endotoxin test(1). In lieu of detailing the exact procedure here (which can be found in reference(1)), a “Bench Sheet” is provided that can be used in conjunction with the USP protocol.