Ensuring Safety Through USP
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 injectables. 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 are performed. This testing confirms that there are no components of the formulation that will interfere with the bacterial endotoxin test and that the method used is sensitive enough to provide meaningful, accurate data.
What Are Endotoxins?
Bacterial endotoxins, found in the cell wall of gram-negative bacteria, are members of a class of phospholipids called lipopolysaccharides (LPS). Endotoxins are released when the bacterial cells are disrupted or upon the destruction of the bacterial cell. Examples of bacteria species that contain endotoxins include Escherichia, Salmonella, Shigella, Pseudomonas, and Haemophilus.
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 have on human and animal health, it’s important to test medical devices, injectables, raw chemicals, 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 that can lead to aseptic shock and potentially death.
Did You Know?
Did you know that a compounded preparation that passes a sterility test is not necessarily guaranteed to be free of endotoxins? Due to the potential effects on human and animal health, it is essential to make sure that your product is endotoxin-free through the USP <85> Bacterial Endotoxin Test. Learn more about endotoxin testing from an Eagle’s microbiologist in this video.
- Eagle conducts LAL (Limulus Amoebocyte Lysate) testing and uses the Turbidimetric method, which is based on the development of turbidity after cleavage of an endogenous substrate.
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