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Establishment and Validation of Gold Amalgamation Method for the Quantitation of Thimerosal in Biological Products  

Kim, Byung-Chul (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation Korea Food & Drug Administration)
Kim, Do-Keun (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation Korea Food & Drug Administration)
Hong, Sung-Hwa (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation Korea Food & Drug Administration)
Kim, Yeon-Hee (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation Korea Food & Drug Administration)
Lim, Jong-Mi (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation Korea Food & Drug Administration)
Won, Yun-Jung (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation Korea Food & Drug Administration)
Kim, Seok-Hwan (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation Korea Food & Drug Administration)
Hong, Ji-Young (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation Korea Food & Drug Administration)
Yun, Young-Min (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation Korea Food & Drug Administration)
Kim, Jae-Ok (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation Korea Food & Drug Administration)
Publication Information
YAKHAK HOEJI / v.55, no.4, 2011 , pp. 284-288 More about this Journal
Abstract
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.
Keywords
thimerosal; amalgamation; atomic; biological products; vaccine;
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  • Reference
1 Blood mercury flow injection cold vapor atomic absorption (U.S. CDC Method ITB003A, 2004.9).
2 Mercury in solids and solutions by thermal decomposition, amalgamation, and atomic absorption spectrophotometry (U.S. EPA Method 7473, 2007.2).
3 Darling, A. J., Boose, J. A. and Spaltro, J. : Virus assay methods, accuracy and validation. Biologicals. 26, 105 (1998).   DOI   ScienceOn
4 식품의약품안전청 : 의약품등 분석법의 밸리데이션에 대한 가이드 라인 (2004).
5 ICH Topic Q2(R1) Validation of Analytical Procedure : Text and Methodology (2005).
6 한국생산기술연구원 국가청정생산지원센터 : 주요 국제환경 협약 및 환경규제 연구보고서 (2004).
7 생물학적제제 기준 및 시험방법(식품의약품안전청 고시 제2010- 39호, 2010.6.3).
8 대한약전 제9개정(식품의약품안전청 고시 제2007-89호, 2007. 12.18).
9 Hornig, M., Chian, D. and Lipkin, W. L. : Neurotoxic effect of postnatal thimerosal are mouse strain dependent. Molecular Psychiatry 9, 1 (2004).   DOI   ScienceOn
10 식품의약품안전청 : 백신 중 치메로살의 감량 등 허가 및 심사 가이드라인(2005).
11 2007 식품의약품안전백서(식품의약품안전청 행정간행물등록번호 제11-147000-000139-10, 2007.8).
12 생물학적제제 등의 품목허가심사 규정(식품의약품안전청 고시 제 2008-17호, 2008.12.8.).
13 국가검정 대상 의약품 지정 등에 관한 규정(식품의약품안전청 고 시 제2008-50호, 2008.8.8).
14 약사법 시행규칙(보건복지가족부령 제77호) [별표3] 생물학적제제등 제조 및 품질관리기준 (2008).