Detection and Quantification of Gram-Negative Bacterial Endotoxin Contamination in Nanoparticle Formulations Using the Kinetic Chromogenic LAL Assay

This document describes a protocol for a quantitative detection of Gram-negative bacterial endotoxin in nanoparticle preparations using a kinetic chromogenic Limulus Amebocyte Lysate (LAL) assay. The protocol is based on the USP standard 85 “Bacterial endotoxin test”.