Detection and Quantification of Gram-Negative Bacterial Endotoxin Contamination in Nanoparticle Formulations Using the Gel-Clot LAL Assay
This document discusses the quantitative detection of Gram-negative bacterial endotoxin in nanoparticle preparations using the gel-clot Limulus Amebocyte Lysate (LAL). The protocol for this assay is based on instructions provided with the reagents from Associates of Cape Cod as well as the USP standard 85 “Bacterial endotoxin test” . In lieu of detailing the exact procedure here (which can be found in reference , a “Bench Sheet” is provided that can be used in conjunction with the USP protocol.
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