Sterile Basics of Compounding: Allowable Endotoxin Levels in Parenteral Preparations

Inadvertent administration of endotoxins to humans may result in a number of events, ranging from fever, through a cascade of pathogenic responses, to death. Endotoxins are potent, toxic, and very stable and are present in many pharmaceutical ingredients and on surfaces that come into contact with preparations formulated for parenteral administration. Endotoxins are very difficult to eliminate in a final preparation, therefore, procedures are generally directed at eliminating endotoxins during the preparation process. This article discusses the allowable endotoxin levels in parenteral preparations.