Optimization Sonication Time and Dilution Factor in Determining the Concentration of Endotoxin Challenge Vial with Kinetic Turbidimetric Method

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Abstract ECV has a specification certificate of analysis (CoA) worth 9616 EU/mL where the limit of acceptability recovery is in the range of 50 – 200 percent (4808 EU/mL - 19232 EU/mL). The verification results of ECV concentration with kinetic turbidimetry method showed recovery outside the lower limit of the predetermined range less than 50 percent. This is due to endotoxin adsorbed onto the surface of the glass. To get a recovery that goes within the limits of acceptability then do the time variation of sonication (5; 10; 15; 20; 25; 30) minutes and variations of the dilution factor of 10−4; 10−5. The result showed that the optimum sonication time was 25 minutes with a 10−4 dilution factor. The average concentration of ECV obtained worth 7828,98 EU/mL with a recovery 81,4 percent. The validation test showed a significant correlation coefficient values (-0,9963); and the precision of data with CV < 2/3 CVH, control of graph showed that the data was homogenic; the value of LOD (1070,6823 EU/mL); LOQ (3568,9411 EU/mL) and percent recovery value was 81,0844 percent. Suggested for further research to optimize the use of buffer solution as a solvent, but it also can optimize the temperature and the frequency of the sonication process.

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