Wako, 201-10421, 0.1mol/L Tris-HCl Buffer Solution (pH 7.3)

, Endotoxin is a component of the outer membrane of Gram-negative bacteria and is a lipopolysaccharide (LPS). Since endotoxin causes serious symptoms such as fever and shock in the human body, the bacterial endotoxin test for pharmaceuticals, especially parenteral drugs, is important. Since J. Levin and F. B. Bang discovered that endotoxin gels an extract from horseshoe crab amebocytes (Limulus amebocyte lysate, or LAL), bacterial endotoxin detection by the Limulus test has been widely used., This method, known as the limulus test, was adopted in the US Pharmacopoeia in 1980, and later in 1988 in the Japanese Pharmacopoeia as well., , Gelation reaction of the LAL reagent is known to be influenced very much by pH. The optimum pH for LAL gelation test is pH 6 to 7.5, and pH 7.3 using a toxinometer. In case the pH of the sample is outside this range, the pH must be adjusted with endotoxin-free sodium hydroxide solution or hydrochloric acid solution., The product is a buffer solution already adjusted, to be used with samples such as a drug which may cause changes in pH levels, in order to omit the above process of adjustment., When the LAL reagent is dissolved with the product instead of distilled water, the reagent will have a buffer action., pH 7.3 at 30 degrees centigrade