In pharmaceutical and biomedical manufacturing, parenteral products must undergo Bacterial Endotoxins Testing (BET) to meet appropriate safety standards before they are released to the market. Since the gel clot Limulus Amebocyte Lysate (LAL) assay was first developed for BET, other more advanced variations of the LAL assay have emerged. These assays can not only determine the presence/absence of endotoxin in a sample, but also reveal how much endotoxin is present. This quantitative data facilitates compliance to quality control (QC) testing and data integrity standards for a wide range of applications.
There are three main types of quantitative LAL tests that are widely used for BET: chromogenic, turbidimetric and recombinant Factor C (rFC) assays. Here we focus specifically on the chromogenic LAL assay and outline the method, key benefits and applications of the Kinetic-QCL® Kinetic Chromogenic LAL Assay.
When using these chromogenic LAL assays for bacterial endotoxin QC testing, our fully integrated WinKQCL® 6 Software, which has been specially designed to support BET, can ensure the reliability and efficiency of your testing, including automating data collection, management and reporting processes.