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Certified Reference Material of Tylosin Tartrate

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Reference Materials in Measurement and Technology (RMMT 2022)

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Abstract

Antibiotics are widely used to combat various infectious diseases in animals. The uncontrolled use of antibiotics leads to antibiotic residues in food products that are easily transmitted to humans through food chains. The quality of medicinal products and the food safety of animal products is controlled by determining the content of drug residues using reference materials (RMs). In this study, we develop a certified RM (CRM) for the composition of tylosin tartrate. The methodology involved selection of a procedure for preparing the initial RM and methods for measuring the content of tylosin tartrate. As a result, HPLC was used for quantitative determination of the certified value of the measured quantity (mass fraction of tylosin). In accordance with RMG 93-2015 and GOST ISO Guide 35-2015, the standard uncertainty of the RM certified value from the characterization method, heterogeneity and instability of the material was estimated. The expanded uncertainty of the certified value was calculated. A new CRM GSO 11632-2020 for the composition of tylosin tartrate was approved. The CRM can be used for certifying measurement methods and controlling the measurement results of the mass fraction of tylosin in veterinary medicinal products, food, and animal feed.

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Notes

  1. 1.

    State Register of Medicines for Veterinary Use (2022) Available via Galen. https://galen.vetrf.ru/#/registry/pharm/registry?page=1. Accessed 15 July 2022 (In Russ.).

    Veterinary drugs Republic of Belarus. Available via vetsnab.info. https://vetsnab.info/veterinarnye-preparaty/. Accessed 15 July 2022 (In Russ.).

    State register of veterinary drugs and feed additives of the Republic of Kazakhstan. Available via Ministry of Agriculture of the Republic of Kazakhstan. https://www.gov.kz/memleket/entities/moa/documents/details/471966?lang=ru. Accessed 15 July 2022 (In Russ.).

  2. 2.

    Tylosin (2022) Merck. https://www.sigmaaldrich.com/DE/en/substance/tylosin916101401690. Accessed 17 October 2022.

  3. 3.

    Foundation for Ensuring the Uniformity of Measurements (2022). https://fgis.gost.ru/fundmetrology/registry/19. Accessed 17 October 2022 (In Russ.).

  4. 4.

    Tylosin LOT F0C008 (2022) Available via. https://static.usp.org/pdf/EN/referenceStandards/certificates/1703805-F0C008.pdf. Accessed 17 October 2022.

  5. 5.

    Tylosin Tartrate (2022) Available via. https://store.usp.org/product/1703850. Accessed 17 October 2022.

  6. 6.

    Tylosin Tartrate (2022) Available via. https://store.usp.org/product/1703850. Accessed 17 October 2022.

  7. 7.

    MU A-1/063 Method for Measuring the Content of Tylosin in the Tylosin Tartrate Substance by the Microbiological Method (2020). Available via FIF EUM. https://fgis.gost.ru/fundmetrology/registry/16/items/1010594. Accessed 7 October 2022 (In Russ.).

  8. 8.

    GET 208-2019 State primary standard of units of mass (molar) fraction and mass (molar) concentration of organic components in liquid and solid substances and materials based on liquid and gas chromatography-mass spectrometry with isotope dilution and gravimetry: D. I. Mendeleyev Institute for Metrology. Available via FIF EUM. https://fgis.gost.ru/fundmetrology/registry/12/items/1382717. Accessed 17 October 2022 (In Russ.).

  9. 9.

    GSO 11632-2020 Reference materials of the composition of tylosin tartrate. Available via FIF EUM. https://fgis.gost.ru/fundmetrology/registry/19/items/1384760. Accessed 17 October 2022 (in Russ.).

Abbreviations

CRM:

Certified reference material

HPLC:

High performance liquid chromatography.

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Acknowledgements

The research was carried out at the Russian State Center for Animal Feed and Drug Standardization and Quality (VGNKI) as part of the research work on the project “Development of certified reference materials (GSO) of tylosin and doxycycline” (2019–2020) as part of the State work “Applied scientific research”. All measurements were carried out using the equipment of the Russian State Center for Animal Feed and Drug Standardization and Quality.

Contribution of the Authors

Gulyaeva A. Yu.—general research management, development of the research concept, collection and analysis of experimental data, collection of literature data, preparation of documents on RM tests for type approval, writing a draft of the article; Khrushchev A. Y.—acquisition and analysis of experimental data on IR spectroscopy, revision of the text; Kolyachkina S. V.—conducting research, developing methods, experimental data acquisition; Muravieva V. B.—conducting research, developing methods, experimental data acquisition; Antonova S.V.—collection of literary data, revision of the text.

Conflict of Interest

The article was prepared on the basis of a report presented at the V International Scientific Conference “Reference Materials in Measurement and Technology” (Yekaterinburg, September 13–16, 2022). The article was admitted for publication after the abstract was revised, the article was formalized, and the review procedure was carried out.

The version in the Russian language is published in the journal “Measurement Standards. Reference Materials” 2023;19(2):19–34. (In Russ.) https://doi.org/10.20915/2077-1177-2023-19-2-19-34.

Author information

Authors and Affiliations

  1. Department for Pharmaceutical Medicines Safety Control, 5 Zvenigorodskoye highway, Moscow, 123022, Russia

    Anastasia Yu. Gulyaeva & Svetlana V. Kolyachkina

  2. Laboratory for Quality Control of Medicines, 5 Zvenigorodskoye highway, Moscow, 123022, Russia

    Alexei Y. Khrushchev, Victoria B. Muravieva & Svetlana V. Antonova

  3. The Russian State Center for Animal Feed and Drug Standardization and Quality, Moscow, Russia

    Anastasia Yu. Gulyaeva, Alexei Y. Khrushchev, Svetlana V. Kolyachkina, Victoria B. Muravieva & Svetlana V. Antonova

Authors
  1. Anastasia Yu. Gulyaeva
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  2. Alexei Y. Khrushchev
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  3. Svetlana V. Kolyachkina
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  4. Victoria B. Muravieva
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  5. Svetlana V. Antonova
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Corresponding author

Correspondence to Anastasia Yu. Gulyaeva .

Editor information

Editors and Affiliations

  1. UNIIM—Affiliated Branch of the D. I. Mendeleyev Institute for Metrology, Yekaterinburg, Russia

    Egor P. Sobina

  2. UNIIM—Affiliated Branch of the D. I. Mendeleyev Institute for Metrology, Yekaterinburg, Russia

    Sergey V. Medvedevskikh

  3. UNIIM—Affiliated Branch of the D. I. Mendeleyev Institute for Metrology, Yekaterinburg, Russia

    Olga N. Kremleva

  4. All-Russian Scientific Research Institute for Optical and Physical Measurements, Moscow, Russia

    Ivan S. Filimonov

  5. All-Russian Scientific Research Institute for Metrological Service, Moscow, Russia

    Elena V. Kulyabina

  6. D. I. Mendeleyev Institute for Metrology, Saint Petersburg, Russia

    Anna V. Kolobova

  7. Saint Petersburg State University, PetroAnalytica LLC, Saint Petersburg, Russia

    Andrey V. Bulatov

  8. All-Russian Scientific Research Institute of Physicotechnical and Radio Engineering Measurements, Moscow, Russia

    Vladimir I. Dobrovolskiy

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Gulyaeva, A.Y., Khrushchev, A.Y., Kolyachkina, S.V., Muravieva, V.B., Antonova, S.V. (2024). Certified Reference Material of Tylosin Tartrate. In: Sobina, E.P., et al. Reference Materials in Measurement and Technology . RMMT 2022. Springer, Cham. https://doi.org/10.1007/978-3-031-49200-6_1

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