Detection and Quantification of Gr am Negative Bacterial Endotoxin Contamination in Nanopart icle Formulations by Kinetic Turbidity LAL Assay

Standard Number STE - 1.2
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 a kinetic turbidity Limulus Amebocyte Lysate(LAL) assay. The protocol is based on the USP standard 85 “Bacterial endotoxin test”(1).