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Application of the Protein Content Test in Therapeutic Human Albumin : Variable Pathlength Extension Spectrophotometry

첫 페이지 보기
  • 발행기관
    한국에프디시규제과학회(구 한국에프디시법제학회) 바로가기
  • 간행물
    KFDC규제과학회지(구 FDC법제연구) KCI 등재후보 바로가기
  • 통권
    19권 1호 (2024.06)바로가기
  • 페이지
    pp.39-42
  • 저자
    Song Youl Yoon, Da Hee Kang, Hye-Ryeon Heo, Seung-Rel Ryu, Chulhyun Lee, Eunhye Park, Jihwa Kim, Hokyung Oh
  • 언어
    영어(ENG)
  • URL
    https://www.earticle.net/Article/A456939

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초록

영어
Human albumin solutions which are used in medical and surgical conditions are required national lot release regulatory before releasing into the market. Testing for the albumin content is the key component and the Kjeldahl method, which can be time-consuming processes and safety concerns regarding sulfuric acid use, is currently the official test method for albumin content in Ministry of Food and Drug Safety, Republic of Korea. In this study, we applied SoloVPE, a new UV-vis spectroscopic technology using a variable path length extension to quantify albumin content for quality control purposes regarding human albumin solution. With its validation, a strong correlation was shown between the Kjeldahl method and SoloVPE. Our findings can help improve the current testing methods for albumin content and provide better quality controls for human albumin solutions.

목차

Abstract
I. Introduction
II. Materials and methods
1. Materials
2. Variable pathlength extension spectrophotometry (SoloVPE)
3. Semi-micro Kjeldahl
4. Data analysis
III. Results
1. Validation of SoloVPE
2. Comparison between the semi-micro Kjeldahl and SoloVPE methods
3. Application of the quality control test to therapeutic human albumin
IV. Discussion
Conflict of interest
Acknowledgements
References

저자

  • Song Youl Yoon [ Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Republic of Korea ]
  • Da Hee Kang [ Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Republic of Korea ]
  • Hye-Ryeon Heo [ Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Republic of Korea ]
  • Seung-Rel Ryu [ Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Republic of Korea ]
  • Chulhyun Lee [ Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Republic of Korea ]
  • Eunhye Park [ Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Republic of Korea ]
  • Jihwa Kim [ Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Republic of Korea ]
  • Hokyung Oh [ Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Republic of Korea ] Corresponding Author

참고문헌

자료제공 : 네이버학술정보

간행물 정보

발행기관

  • 발행기관명
    한국에프디시규제과학회(구 한국에프디시법제학회) [The Korean Society of Food, Drug and Cosmetic Regulatory Sciences]
  • 설립연도
    2006
  • 분야
    의약학>약학
  • 소개
    본회는 의약품, 의약외품, 의료기기, 화장품 및 건강기능식품 등과 관련된 국내·외의 각종 법령과 규정 등에 대한 연구와 발표 등을 통하여 합리적이고 투명한 법령과 규정의 제·개정 및 정책개발에 기여함으로써 관련 산업의 발전과 국민의 건강증진에 기여하며 회원 상호 간의 친목을 도모함을 목적으로 한다.

간행물

  • 간행물명
    KFDC규제과학회지(구 FDC법제연구) [Regulatory Research on Food, Drug and Cosmetic]
  • 간기
    반년간
  • pISSN
    2799-8940
  • 수록기간
    2006~2026
  • 십진분류
    KDC 518 DDC 615

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