ABSTRACT
Endotoxin is a powerful biological response modifier that can elicit a wide range of effects, including fever, shock, and death. Endotoxin contamination of parenteral medications is of particular concern because these products are administered directly into the body, bypassing the protective barriers of the skin and the intestinal wall. Endotoxin is a structural component of the cell envelope of Gram negative bacteria, which consists of an inner and an outer membrane. The inner (cytoplasmic) membrane is a typical biological membrane consisting of a phospholipid bilayer with embedded proteins and is similar in structure to the cytoplasmic membrane of gram positive cells. The properties of endotoxin that have been discussed are generalizations and differ in degree between species or strains. They can also differ between cultures of the same organism grown in different media. The term “Control Standard Endotoxin” is commonly used for such secondary endotoxin standards.
