VALIDATING THE PROCEDURE OF DETERMINATION OF PHENOL CONTENT IN VACCINE BY REVERSE PHASE CHROMATOGRAPHY METHOD

Abstract

Phenol (C₆H₆O) is used as a preservative in vaccines and is approved by the FDA. To ensure the quality of test results and comply with the provisions of ISO/IEC 17025:2017, NRA and GLP, we perform the study "Validation of the process for determining phenol content in vaccines by reverse - phase chromatography with the goals validating the procedure "determination of phenol content in vaccines by reversed-phase chromatography"and estimating the measurement uncertainty of Typhoid Vi vaccine.The study used the experimental description method and data processing using Microsoft Excel software to obtain the following results: precision (1.23%), accuracy (recovery 100.63%), robustness (there was no average difference in the results of phenol content on Typhoid Vi samples of the two groups), specificity (no substance detected in Quimihib vaccine), linearity (accuracy and precision at the points of Standard curve meets AOAC standards), LOQ is 9.47 ppm. The measurement uncertainty of Typhoid Vi vaccine is 0.24 µg/dose.The results show that the procedure "determination of phenol content in vaccines by reversed-phase chromatography" is valuable and suitable for testing phenol content at the National Institute for Control of Vaccines and Biologicals.