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

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).