Selected Document Category:Published Document
Source:Nanotechnology Characterization Laboratory
Anticipated Publication Year:
Publication Year:2011
Identifier:STE - 1.3
Document Title:Detection and Quantification of Gr am Negative Bacterial Endotoxin Contamination in Nanopart icle Formulations by 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 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.

Keywords:BacterialEndotoxin, LAL
Type of Document:e. Specification
Issues Areas:Measurement and Characterizations
Health, Safety, and Environment
Primary Category:Chemicals e.g. pesticides, pharmaceuticals, paints, basic chemicals
Additional Categories
Goal or Need:
Intended Stakeholders:
Is it Being Implemented:
Submitter's Name:Admin
Submitter's e-mail:SCulley@ansi.org
Submitter's Company:ANSI
Additional Comments:
Contact for Additional Info:http://ncl.cancer.gov/working_assay-cascade_download.asp