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New Direction in the Determination of Bacterial Endotoxins: Analysis Using Recombinant Factor C

  • STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
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Pharmaceutical Chemistry Journal Aims and scope

A comparative study of methods for the determination of bacterial endotoxins using recombinant reagents confirmed that the analytical results did not differ from the values obtained using a chromogenic kinetic test with LAL reagent of natural origin. It was experimentally confirmed that recombinant reagents did not respond to the presence of β-glucan impurities, thus excluding the possibility of false-positive reactions.

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Acknowledgments

The work was performed in the framework of State Task No. 056-00001-2200 for SCEEMP, Ministry of Health of Russia, for applied scientific research (State Acct. No. NIR 121021800098-4). We thank and recognize the companies LAL-Consulting Ltd., OOO Altimed, and OOO bioMerieux Rus for collaboration in writing the scientific article.

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Authors and Affiliations

  1. State Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051, Russia

    O. V. Shapovalova, N. P. Neugodova, G. A. Sapozhnikova & E. O. Stepanyuk

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  1. O. V. Shapovalova
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  2. N. P. Neugodova
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  3. G. A. Sapozhnikova
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  4. E. O. Stepanyuk
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Corresponding author

Correspondence to O. V. Shapovalova.

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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 56, No. 8, pp. 52 – 58, August, 2022.

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Shapovalova, O.V., Neugodova, N.P., Sapozhnikova, G.A. et al. New Direction in the Determination of Bacterial Endotoxins: Analysis Using Recombinant Factor C. Pharm Chem J 56, 1133–1139 (2022). https://doi.org/10.1007/s11094-022-02763-3

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  • DOI: https://doi.org/10.1007/s11094-022-02763-3

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