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

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

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Standard Number STE-1.4
Organization Nanotechnology Characterization Laboratory USA
Level National
Category Test Method | Characterization | Measurement
Status
  • SEP 2020 Published
ABSTRACT
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”.