Considerations When Determining Endotoxin Limits For Injectable Drugs Used In Pediatric Medicine

Endotoxins are a powerful pyrogen that, when they gain parenteral access to the body, can lead to serious symptoms and even septic shock and death. To address the risks that endotoxins pose, injectable pharmaceuticals and medical devices as well as their raw materials, are subjected to strictly regulated endotoxin testing. The Limulus amebocyte lysate (LAL) assay has been established as the gold standard for endotoxin testing due to its sensitivity and specificity. Endotoxin limits are set for each newly developed injectable drug product, taking into consideration its dose, route and time of administration, and disease indications. Here we explore how weight is also used to adjust the dose administered and determine endotoxin limits.