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Pharmaceutical Chemistry Journal

, Volume 53, Issue 3, pp 267–271 | Cite as

Method Development for Determining Prekallikrein Activator in Medicinal Preparations of Human Immunoglobulins and Albumin

  • O. G. Kornilova
  • M. A. Krivykh
  • E. S. Konovalova
  • I. V. Borisevich
STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
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Method development for determining prekallikrein activator in medicinal preparations of human immunoglobulins and albumin found that the adequacy of chromogenic determination of prekallikrein activator depends on the activity of the used prekallikrein reagent, the quantitative component ratio in the reaction mixture and its incubation time, and the concentration of employed chromogenic reagent. Acceptance criteria for commercial prekallikrein reagents are justified. The main method parameters and validation test results confirming the linearity in the range 0 – 35 IU/mL, accuracy, and intralaboratory precision are presented and correspond to those for biological analytical methods. The elaborated method can be used for quality assessment of prekallikrein activator content in medicinal preparations of human immunoglobulins and albumin.

Keywords

prekallikrein activator human immunoglobulin preparations for intravenous injection human albumin preparations specific safety 

Notes

Acknowledgments

The work was performed in the framework of a State Task for SCEEMP, Ministry of Health of the RF, No. 056-00023-18-02 for applied research (State Account No. NIR AAAA-A18-118021590046-9).

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • O. G. Kornilova
    • 1
  • M. A. Krivykh
    • 1
  • E. S. Konovalova
    • 1
  • I. V. Borisevich
    • 1
  1. 1.Scientific Center for Expert Evaluation of Medicinal ProductsMinistry of Health of the Russian FederationMoscowRussia

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