Detection and Quantification of Gr am Negative Bacterial Endotoxin Contamination in Nanopart icle Formulations by Kinetic Turbidity LAL Assay
| Standard Number | STE - 1.2 |
|---|---|
| Organization |
Nanotechnology Characterization Laboratory
|
| Level | National |
| Category | Specification |
| Status |
|
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).