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KMID : 0370220110550040284
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Yakhak Hoeji
2011 Volume.55 No. 4 p.284 ~ p.288
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Establishment and Validation of Gold Amalgamation Method for the Quantitation of Thimerosal in Biological Products
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Kim Byung-Chul
Kim Do-Keun
Hong Seung-Hwa
Kim Yeon-Hee
Lim Jong-Mi
Won Yun-Jung
Kim Seok-Hwan
Hong Ji-Young
Yun Young-Min
Kim Jae-Ok
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Abstract
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The test method for biologics of lot release system is based on ’Test procedure and specification for biological products,’ generally, thimerosal content is measured by chemical analysis using O.D. In this study, the comparative analysis was carried out using the gold amalgamation method for thimerosal content was compared to the existing methods, which are described above. The gold amalgamation method, which uses atomic absorption spectrophotometry, was meets all the method validation acceptance criteria. It is considered to be proper as the assay and identification test for thimerosal. In this study, the comparative analysis was performed three times. As a result, gold amalgamation method is more convenient and easy to perform as this assay doesn’t have pre-treatment procedure. Also this assay showed good precision and reproducibility compared to the conventional method. Therefore, it is appropriate to alternate the assay method of thimerosal from the conventional chemical analysis to gold amalgamation method to improve the credibility of lot release system and the quality control of biologics, by standardizing test method.
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KEYWORD
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thimerosal, amalgamation, atomic, biological products, vaccine
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