There is never a convenient time for an invalid Limulus Amebocyte Lysate (LAL) test result. While the horseshoe crab-derived LAL reagent is the most sensitive and reliable method available for bacterial endotoxin testing, the progression of kinetic chromogenic technology has allowed us to make improvements by fusing it into Endosafe® LAL reagent cartridges.
Compendial FDA-Licensed Kinetic Chromogenic LAL Cartridges
Traditional endotoxin testing has had a history of pain points, including long turnaround times, extensive training, and multiple steps for assay preparation. To make matters worse, an invalid LAL test result can potentially cripple your manufacturing timelines.
The Endosafe LAL cartridge technology is the innovative response to the need for a more precise, objective, and faster quantitative results in the kinetic chromogenic method. A novel technology designed to optimize and refine the usage of LAL, our Endosafe LAL cartridges utilize 95% less horseshoe crab raw material and accessories than gel-clot and KTA methods. The disposable cartridges contain precise amounts of our FDA-licensed chromogenic LAL reagent, chromogenic substrate, and controls needed to measure color intensity directly related to the endotoxin concentration in a sample and obtain rapid, accurate results.
Automatically performing a duplicate sample and positive product control, they satisfy the harmonized BET chapters USP or Ph.Eur. for LAL testing. Each cartridge is manufactured according to rigid quality control procedures to ensure test accuracy and product stability and is compliant with existing global harmonized regulatory guidelines.