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<p>An analytical review of quantitative determination methods for blood coagulation factor VIII in medicinal products and standard samples used for these purposes in international pharmaceutical practice is presented. Methodological features of the development and certification of batches of the international reference standard of blood coagulation factor VIII and batches of the reference standard of the European Pharmacopoeia are given. It is shown that domestic manufacturers need a national pharmacopoeial reference standard to ensure proper quality control of blood coagulation factor VIII medicinal products. The need to develop a pharmacopoeial reference standard of blood coagulation factor VIII, calibrated in international units, for the State Pharmacopoeia of the Russian Federation is established. The implementation of several approaches is proposed for further development of the national reference standard.</p>

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Methodology for Determining the Potency of Blood Coagulation Factor VIII in Medicinal Products

  • 期刊论文

  • 发表日期：

    2025年10月1日

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  • E. L. Tyagunova,
  • A. S. Kasimova,
  • O. G. Kornilova,
  • M. A. Krivykh,
  • N. D. Bunyatyan

摘要

An analytical review of quantitative determination methods for blood coagulation factor VIII in medicinal products and standard samples used for these purposes in international pharmaceutical practice is presented. Methodological features of the development and certification of batches of the international reference standard of blood coagulation factor VIII and batches of the reference standard of the European Pharmacopoeia are given. It is shown that domestic manufacturers need a national pharmacopoeial reference standard to ensure proper quality control of blood coagulation factor VIII medicinal products. The need to develop a pharmacopoeial reference standard of blood coagulation factor VIII, calibrated in international units, for the State Pharmacopoeia of the Russian Federation is established. The implementation of several approaches is proposed for further development of the national reference standard.