VALIDATING THE PROCEDURE FOR DETERMINATION OF THE PARTITION CONSTANT Kd OF MENINGES CONJUGATE IN MENACTRA VACCINE BY SIZE EXCLUSION CHROMATOGRAPHY METHOD

Abstract

Size exclusion chromatography is a method where separation of different compounds in a solution occurs according to their size. This method is mainly applied in desalting, purification & fractionation, concentration of diluted solutions and determination of molecular weight. In size exclusion chromatography, the molecular size is closely involved in the retention time. The retention time of a particular molecule (with known size) can be used to calculate the partition constant Kd, estimate the molecular size to be tested and confirm if this molecule is intact or not. This study was conducted to validate the procedure for determining the partition constant (Kd) of Meninges conjugate in Menatra vaccine and to estimate the uncertainty of measurement in the test sample. The method used in the study was descriptive experimental method in the laboratory. The evaluation results confirmed the suitability of the system, precision (repeatability and intermediate reproducibility) and specificity that meets ICH (International Council for Harmonisation) and WHO (World Health Organization) standards. The expanded uncertainty on the Menactra sample is 0,0128. The testing was valid and in accordance with the laboratory conditions of the Department. The uncertainty of the test sample was consistent with the Kd result of meninges conjugate in the sample.