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) |
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). |