METHOD FOR EVALUATION OF ENDOTOXIN LEVEL IN HEMOGLOBIN SOLUTION

摘要

A procedure for endotoxin level evaluation in the hemoglobin solution by means of application LAL kinetic-turbidimetric method at the wave length of 650 nm and 660 nm by use of adequate filters and adequate modifications of hemoglobin sample of 10%w/v. Hemoglobin solution of 10%w/v is diluted up to the concentracion of 10mg/ml and then incubed in the temperature range of 60-800C/10-20 minutes. Incubed solution is diluted up to the concentracion of 2,5 mg/ml and then tested by application of LAL kinetic-turbidimetric method on the wave lengths of 650 nm and 660 nm with application of the appropriate filters. Endotoxin concentrations are read from the standard curve obtained for LAL kinetic-turbodimetric method on the wave-lengths from 650 nm to 660 nm. The test is valid if the value of the positive check of the product is in range of 50-200% in comparison to the pure sample, and the hemoglobin solution is apyrogenic if the endotoxin level read at the sample is <0,595EU/ml (<5,95EU/g hemoglobine).