Kinetic Chromogenic Method

Description

The Kinetic Chromogenic Method is a quantitative assay used to detect bacterial endotoxins in pharmaceutical products, biologics, and medical devices. In this method, endotoxins react with the Limulus Amebocyte Lysate (LAL) reagent, producing a color change. The rate and intensity of the color development are directly proportional to the endotoxin concentration, providing precise measurement.

This method is commonly applied to:
Injectable drugs and parenteral solutions
Ophthalmic products
Biological products and vaccines
Medical devices that contact blood or tissues
Water for injection (WFI) and other pharmaceutical-grade waters