약학회지 (YAKHAK HOEJI)

  • 제55권4호
  • /
  • Pages.284-288
  • /
  • 2011
  • /
  • 0377-9556(pISSN)
  • /
  • 2383-9457(eISSN)
대한약학회 (The Pharmaceutical Society of Korea)
권호 표지

생물학적제제의 치메로살 함량 정량을 위한 가열기화 아말감 흡광도법의 확립 및 검증

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

  • 김병철 (식품의약품안전청 식품의약품안전평가원 국가검정센터) ;
  • 김도근 (식품의약품안전청 식품의약품안전평가원 국가검정센터) ;
  • 홍성화 (식품의약품안전청 식품의약품안전평가원 국가검정센터) ;
  • 김연희 (식품의약품안전청 식품의약품안전평가원 국가검정센터) ;
  • 임종미 (식품의약품안전청 식품의약품안전평가원 국가검정센터) ;
  • 원윤정 (식품의약품안전청 식품의약품안전평가원 국가검정센터) ;
  • 김석환 (식품의약품안전청 식품의약품안전평가원 국가검정센터) ;
  • 홍지영 (식품의약품안전청 식품의약품안전평가원 국가검정센터) ;
  • 윤영민 (식품의약품안전청 식품의약품안전평가원 국가검정센터) ;
  • 김재옥 (식품의약품안전청 식품의약품안전평가원 국가검정센터)
  • 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)
  • 투고 : 2011.07.27
  • 심사 : 2011.08.06
  • 발행 : 2011.08.31
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초록

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.

키워드

참고문헌

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