ABSTRACT
Bacterial endotoxin is the most significant pyrogen in the pharmaceutical industry because of its potency and prevalence. Endotoxin was recently implicated in adverse reactions to injectables made by parenteral manufacturers and compounding pharmacies (1-3). Studies of the etiology of these events suggest measures that may prevent future incidents. The compendia prescribe endotoxin limits for finished injectable products, but there are few limits for active pharmaceutical ingredients (APIs) and excipients. This discussion proposes strategies for setting endotoxin specifications and suggests remedies for testing materials that interfere with the Bacterial Endotoxins Test (BET).
