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

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

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Standard Number STE-1.1
Organization Nanotechnology Characterization Laboratory USA
Level National
Category Specification
Status
  • JAN 2011 Published
  • SEP 2020 Revised
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).