RT Journal Article
SR Electronic
T1 Automation of Microtiter Plate-Chromogenic Substrate LAL Endotoxin Assay Method by Use of a Modified Cetus Pro/Pette Express System
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 61
OP 65
VO 40
IS 2
A1 P. A. Martin
A1 G. L. Gaunnac
A1 K. Tsuji
YR 1986
UL http://journal.pda.org/content/40/2/61.abstract
AB An automated microtiter plate-chromogenic substrate LAL system for the assay of bacterial endotoxin has been developed using a Cetus Pro/Pette EXPRESS® system, modified with the addition of a solid-state incubator block. The automated system assays 96 samples in approximately 22 min. Sensitivity of the automated system is approximately 0.01 EU/ml with a linear assay range from 0.03 to 0.14 EU/ml and the relative standard deviation (RSD) of approximately 6%. The automated microtiter plate-chromogenic substrate LAL system has been validated for testing a variety of pharmaceutical injectable products and materials. The automated system has been shown to represent significant improvements in speed, accuracy, and precision of the LAL assay method for endotoxin.