YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
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Potency Assay of Factor Ⅷ : C Concentrates using the Chromogenic and Clotting Assay

합성기질 및 응고시간을 이용한 혈액응고 제 8인자 역가측정법

  • 강혜나 (식품의약품안전청 생물학평가부) ;
  • 김순남 (식품의약품안전청 생물학평가부) ;
  • 허숙진 (경인지방청 식품의약품안전청 시험분석실) ;
  • 홍성화 (식품의약품안전청 생물학평가부)
  • Published : 2001.10.01
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Abstract

The clotting assay was replaced by the chromogenic substrate assay which is recommended by the European Pharmacopoeia (EP) and the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis based on the reliability convenience and simplicity of the chromogenic assay, A correlation study was carried out with a one-stage factor Ⅷ : C clotting assay and the performance of the chromogenic assay was evaluated using two test kits that fulfilled the requirements of EP for factor Ⅷ concentrates test. Although chromogenic assay has partly differences in measurement principle and standardization, this assay has a high correlation with clotting assay in various types of factor Ⅷ concentrates and factor Ⅷ standard. We conclude that the chromogenic assay for factor Ⅷ : C concentrates correlates well with the clotting assay and shows good analytical performance.

Keywords

References

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