How to calculate the endotoxin limit for a particular product?
In pharmaceutical microbiology, determining the endotoxin limit is an essential step for products that come in contact with the bloodstream, cerebrospinal fluid, or other sterile body sites. The Bacterial Endotoxin Test (BET) or LAL test ensures that injectable or implantable products are safe and free from pyrogenic reactions. This article explains how to calculate the endotoxin limit for your product as per USP <85> , European Pharmacopoeia (EP) , and Japanese Pharmacopoeia (JP) guidelines. 1. Understanding Endotoxin Limits The endotoxin limit defines the maximum allowable endotoxin units (EU) per milligram, milliliter, or per dose of a product. It depends on two major factors: K: The threshold pyrogenic dose of endotoxin per kilogram of body weight. M: The maximum dose of the product administered per kilogram of body weight in one hour. The basic formula as per USP <85> is: Endotoxin Limit (EU/mg or EU/mL) = K / M 2. Understanding...