Test procedure: A BET involves analyzing the liquid sample or sample extract using Limulus Amebocyte Lysate (LAL). LAL is a reagent made from the blood of the horseshoe crab. In the presence of bacterial endotoxins, the lysate reacts to form a clot or cause a color change depending on the technique.

When do you do endotoxin testing?

Any injectable or implantable products labeled as pyrogen-free or sterile must undergo endotoxin testing before release. This protects patients from harmful endotoxin poisoning, and facilitates compliance with regulatory guidelines and cGMP.

How do you calculate endotoxin limits?

If the dose is 1 mg/kg/hr, the endotoxin limit is (5 EU/kg/hr) ÷ (1 mg/kg/hr) = 5 EU/mg. If the dose is 10 mg/kg/hr, the endotoxin limit is (5 EU/kg/hr) ÷ (10 mg/kg/hr) = 0.5 EU/mg. If the dose is 100mg/kg/hr, the endotoxin limit is (5 EU/kg/hr) ÷ (100 mg/kg/hr) = 0.05 EU/mg.