Bacterial Endotoxin Limit (EL) is defined as EL=K/m, where K=5Endotoxin Units (EU) kg of the body weight or 5 EU/kg/hr;m= maximunbolus dose of a product, and the average human body weight is70kg.The maximun Valid Dilution (MVD) of a product is equal to (ELx Concentration of the product)/sensivity of the lysate
Find the EL for a product whose maximun pediatric dose is 4mg/ml/kg and concentration is 20mg/ml. Expressthe EL in EU/ml andEU/mg
If the sensivitty of the lysate is EU/ml, the Endotoxinsoecification per monograph is EU/mg, the maximun bolus dose is1ug/kg/min and the concentration is 0.2mg/ml.CAn the monographspecification be used as the Endotoxin limit? Explain
Calculate the MVD based on problem #2
