Exposure to endotoxins in even small amounts can result in mild symptoms like headache, nausea, and chills or even more severe symptoms like pulmonary toxicity, abortion, pyrogenic fever, and even death (1, 2). Found wherever gram-negative rods exist, endotoxins are unavoidable in the environment and even found in food and water (1). The human gut, which is home to a multitude of gram-negative organisms itself, is designed to filter endotoxins out of our intestines and prevent illness (1).
Endotoxins are the lipopolysaccharides (LPS) that are present in the cell wall of gram-negative bacteria. Found in both living and dead bacterial cells, LPS are released when cells die and the cell wall degrades (1, 2).
Endotoxin exposure becomes particularly important when administering pharmaceuticals. Of particular concern are injectables and intravenous medications that are immediately exposed to the bloodstream of patients.
At MSI, we offer the gold standard testing method for endotoxins which was developed by Associates of Cape Cod over four decades ago. Today’s endotoxin testing methods are easier with a quicker turnaround time. When done in conjunction with the sterility testing of CSPs, you can feel assured your compounded product meets the safety standards of both USP Chapters <71> and <85>.
To get answers to your questions and for pricing information, please feel free to contact our laboratory staff at 713-663-6888.
References
1. Associates of Cape Cod, Inc. Turbidimetric endotoxin testing method. Workshop Training Workbook. PR# 12-044.
2. Magalhaes, P.O., et al. Methods of endotoxin removal from biological preparations: a review. J Pharm Pharmaceut Sci. 10(3):388-404, 2007.