Endotoxin limit

The maximum permitted endotoxin in a product, calculated as K/M. K is the threshold pyrogenic dose, 5 EU/kg for most parenterals and 0.2 EU/kg for intrathecal products, and M is the maximum dose per kg of body weight given in one hour. The limit is expressed per mg, per mL or per unit of product. Together with the lysate sensitivity, it determines the maximum valid dilution for the test.