Question

Bacterial Endotoxin Limit (EL) is defined as EL=K/m, where K=5 Endotoxin Units (EU) kg of the body weight or 5 EU/kg/hr;m= maximun bolus dose of a product, and the average human body weight is 70kg.The maximun Valid Dilution (MVD) of a product is equal to (EL x Concentration of the product)/sensivity of the lysate
Find the EL for a product whose maximun pediatric dose is 4 mg/ml/kg and concentration is 20mg/ml. Expressthe EL in EU/ml and EU/mg

If the sensivitty of the lysate is EU/ml, the Endotoxin soecification per monograph is EU/mg, the maximun bolus dose is 1ug/kg/min and the concentration is 0.2mg/ml.CAn the monograph specification be used as the Endotoxin limit? Explain

Calculate the MVD based on problem #2

Answer 1

1. Lipopolysaccharides which are also known as lipoglycans and endotoxins composed of O-antigen, outer core and an inner core of an Gram Negative bacteria. There is a particular endotoxin limit for every human adult, the limit of pyrogenic threshold is 5EU per kg of body weight.

Calculating dose per mg (m) = 0.001mg/70kgs = 14.3mg/kg

Endotoxin Limit = K/M = 5EU/Kg/ 14.3mg/kg = 0.35EU/mg

If the endotoxin limit is expressed in EU/ml=

0.35 EU/mg x 100mg/ml = 35EU/ml

Maximum Valid Dilution of the product will be then- 35 EU/ml x 20mg/ml= 700EU/mg/ml

Monograph specification cannot be used to calculate the endotoxin limit as every time new calculation for the endotoxin limit in the human should be done.