Detection and Quantification of Gr am Negative Bacterial Endotoxin Contamination in Nanopart icle Formulations by End Point Chromogenic LAL Assay

Standard Number STE-1.1
Organization Nanotechnology Characterization Laboratory USA
Level National
Category Specification
Status
  • JAN 2011 Published
ABSTRACT
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).