Bacterial Endotoxin Limit (EL) is defined as EL=K/m, where K=5 Endotoxin Units (EU) kg of the...

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

Solutions

Expert Solution

1. Endotoxins are the agents of pathogenicity particularly liposaccharides of the gram negative bacteria which are involved in gram negative shock.There are several tests in use to detect the levels of endotoxins in the sample or product. These endotoxin limits which are mentioned in most of the pharmacopeial monographs should not exceed a given endotoxin concentration.

Here given in the question above,

K = 5 Endotoxin Units ( EU)kg

M= The maximum bolus dose of drug per kg of body weight( Given the standard adult human body weight is 70kgs)

= .001mg/70kgs = 1.4285mg/kg

Endotoxin limit = k/m = 5 EU/Kg / 1.4285 =352.112 EU/mg

Expressing In EU/ml = 352.112EU/mg x 100mg/ml = 35211.2 EU/ml

The maximum Valid Dilution = ELx Concentration of the product

= 352.112 x 20

= 7,042 EU/mg/ml

The maximum valid dilution is the maximum allowable dilution of a specimen, it is calculated by multiplying endotoxin limit with the concentration, where the endotoxin limit concentration is specified by individual monograph in terms of volume.

gladiator answered 1 year ago

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