Lonza, N186, Control Standard Endotoxin for PYROGENT® Gel Clot LAL Assays

Control Standard Endotoxin is a reference endotoxin preparation used with PYROGENT® Gel Clot LAL assays to prepare positive controls and verify expected assay response. This configuration is derived from Escherichia coli strain O55:B5 and contains five vials. The material is used to prepare endotoxin standards at defined concentrations for routine bacterial-endotoxin testing, method setup, and positive-product-control work. In a gel-clot assay, the standard helps confirm that the lysate and test conditions are capable of producing the expected clotting response at the selected sensitivity. It is intended for use with appropriate endotoxin-free water, depyrogenated labware, and compatible PYROGENT procedures. The concentration assigned to each lot is determined from the lot-specific documentation supplied with the material.