Bacterial endotoxin testing for veterinary parenteral products

Chen Yu-Hsien

Abstract

Bacterial endotoxins are considered to be the major cause of pyrogenic response in animals treated with contaminated parenteral products. Bacterial endotoxin testing is routinely required in pharmaceutical industries, not only for the final veterinary products, but also for all of the raw materials, and technical instruments used throughout the production process. For the detection of bacterial endotoxins , various methods have been developed including the in vivo rabbit pyrogen test (PRT) and the in vitro LAL assay with each method having undergone a rigorous verification process, and eventually adopted into the pharmacopoeia as a standard method. We provide an introductory overview of current techniques used to detect bacterial endotoxins in veterinary pharmaceutical products, including traditional standard testing methods detailed in the pharmacopoeia as well as novel alternative technologies. We also discuss the current status and future trends for bacterial endotoxin testing of veterinary pharmaceuticals in Taiwan.