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NCL Method STE-1.3

By Barry Neun, Anna Ilinskaya, Marina Dobrovolskaia

Detection and Quantification of Gram Negative Bacterial Endotoxin Contamination in Nanoparticle Formulations by Gel-Clot LAL Assay

Listed in Datasets | publication by group NCL Protocols

Version 1.0 - published on 04 May 2020 doi:10.17917/VZ9M-8351 - cite this

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This document discusses the quantitative detection of Gram negative bacterial endotoxin in nanoparticle preparations using the gel-clot Limulus Amebocyte Lysate (LAL) assay. The protocol for this assay is based on instructions provided with the reagents from Associates of Cape Cod as well as 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.

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