Detection and Quantification of Gr am Negative Bacterial Endotoxin Contamination in Nanopart icle Formulations by Gel-Clot LAL Assay

Detection and Quantification of Gr am Negative Bacterial Endotoxin Contamination in Nanopart icle Formulations by Gel-Clot LAL Assay

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Standard Number STE - 1.3
Organization Nanotechnology Characterization Laboratory USA
Level National
Category Specification
Status
  • JAN 2011 Published
  • SEP 2020 Revised
ABSTRACT
This document discusses the quantitative detection of Gram negative bacterial endotoxin in nanoparticle preparations using the gel-clot Limulus Amebocyte Lysate (LAL). The protocolfor this assay is based on instructions provided withthe reagents from Associates of Cape Code as well as the USP standard 85 “Bacterial endotoxin test(1). In lieu of detailing the exact procedure here (which can be found in reference(1)), a “Bench Sheet” is provided that can be used in conjunction with the USP protocol.