How to calculate the bacterial endotoxin limit of the product?

Bacterial endotoxin test (BET) is very popular test in pharmaceutical industry. Bacterial endotoxin limit is given for most of the pharmacopoeial products. But what to do in case bacterial endotoxin limit is not given for a particular product? 

Horse Shoe Crab

It's become difficult to calculate endotoxin limit of the products. Though formula is already given in the pharmacopoeia for calculation of bacterial endotoxin limit but still people are not able to understand the calculations.

Today, I am explaining how to calculate the bacterial endotoxin limit of product for which bacterial endotoxin limit is not given in pharmacopoeia in my own simple way. 

I bet you, from today onwards you will be able to calculate the bacterial endotoxin limit of any product.

In pharmacopoeia, formula is given for calculation of bacterial endotoxin limit of any product:

Endotoxin limit (EL) = K/M

Where K is threshold pyrogenic dose of endotoxin per kg of body weight

M is maximum dose administered in a single hour period.

For calculation of endotoxin limit, weight of healthy person considered is 70 kg and maximum allowable endotoxin per person (70 kg body weight) will be 5 USP EU/Kg of body weight for any route of administration other than intrathecal for which K is 0.2 USP EU/kg of body weight.

For a person maximum allowable endotoxin will be 70x5= 350 EU (endotoxin unit).

Here K will be 350 EU. 

For maximum dose please refer product leaflet or literature in which detail of maximum dose per day will be mentioned. Ensure maximum recommended dose of product per day shall be considered for calculation. For example for any drug, if the maximum dose is 500 mg per day.

Calculate the endotoxin limit (EL) = K/M = 350 EU/500 mg = 0.7 EU/mg. 

The calculated endotoxin limit will be 0.7 EU/mg.

Thanks!