Detection and Quantification of Gr am Negative Bacterial Endotoxin Contamination in Nanopart icle Formulations by Kinetic Turbidity LAL Assay
Standard Number | STE - 1.2 |
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Organization |
Nanotechnology Characterization Laboratory
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Level | National |
Category | Specification |
Status |
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ABSTRACT
This document describes a protocol for a quantitative detection of Gram negative bacterial endotoxin in nanoparticle preparations using a kinetic turbidity Limulus Amebocyte Lysate(LAL) assay. The protocol is based on the USP standard 85 “Bacterial endotoxin test”(1).