Bacterial Endotoxin Test

Ensuring Safety through USP <85>

As bacterial endotoxins can pose health and safety hazards to patients, USP <85> requires bacterial endotoxin testing to detect and quantify the presence of endotoxins from Gram-negative bacteria in sterile compounds. To ensure patient safety, the quantity of bacterial endotoxins may not exceed threshold limits defined in USP <85>. For each bacterial endotoxin test, inhibition and enhancement testing is performed. This testing confirms that there are no components of the formulation that will interfere with the bacterial endotoxin test, and that the testing used is sensitive enough to provide meaningful, accurate data.

Eagle's Bacterial Endotoxin Testing Process

Eagle uses the turbidimetric technique, which uses the change in gel turbidity to detect the activation of Limulus Ameboycte Lysate (LAL) reagent induced by endotoxins. The LAL is added to the test sample to make a solution. If endotoxins are present, then the clotting reaction of the LAL reagent produces a solid mass (i.e., a clot or gel) in the solution.

What are Endotoxins?

Bacterial endotoxins, found in the cell wall of gram-negative bacteria, are members of a class of phospholipids called lipopolysaccaharides (LPS). Endotoxins are released when the bacterial cells are disrupted or upon the destruction of the bacterial cell.  Examples of bacteria that contain endotoxins include Escherichia, Salmonella, Shigella, Pseudomonas, and Haemophilius.

Why Test for Endotoxins?

It’s essential to test your sample for bacterial endotoxins to help ensure patient safety. Due to the potentially harmful effects that endotoxins can cause on human and animal health, it’s important to test medical devices, injectables, raw chemical, API, excipients, process water, container closures, and other components that come into contact with the bloodstream or spinal fluid. Endotoxins can cause fever and a wide range of other possible effects including aseptic shock and potentially death.