A significant portion of the scientific effort has been devoted to the detection of endotoxins in pharmaceutical solutions, as they pose major health threats as contaminants even in minute amounts. Conventional methods based on the biological response of endotoxins have been well-established, but as technology advances, many limitations surfaced in the recent years. As a result, information obtained by chemical analytical methods becomes valuable in crossvalidating these results. In addition to providing an overview on the main strategies for detecting the presence of endotoxins, the biological methods are compared with the chemical techniques. The review also investigates future advances aimed toward a more accurate, reliable, and convenient endotoxin test.
Keywords: Analytical method; LAL; LPS; Limulus Amebocyte Lysate; MS; endotoxin detection; lipopolysaccharide; mass spectrometry; pharmaceuticals.