Skip to main content
SpringerLink
Log in

Standardization of the Method for Determining Hemagglutinin Content in Human Immunoglobulin Preparations in Russia

  • Published:
Pharmaceutical Chemistry Journal Aims and scope

Documentation for standardization of the method for determining hemagglutinins (HAs) in human immunoglobulin preparations used in Russia is presented. The proposed general pharmacopoeial monograph “Determination of anti-A and anti-B hemagglutinins in medicinal preparations of human immunoglobulin” allows quality control of human immunoglobulin preparations for HAcontent using indirect hemagglutination under standard conditions. The positive and negative components of the domestic standard sample (SS) of HAs contain 1:32 anti-A and 1:16 anti-B, respectively; less than 1:2 anti-A and -B; and 1:64 components of the HA content limit. Introduction of the SS for contents of anti-A and anti-B HAs into pharmacopoeial practice would ensure that results obtained in various ranges are accurate and enable the quantitative contents of the corresponding HAs in human immunoglobulin preparations to be determined.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. R. Padmore, Transfusion, 55, S59-S64 (2015); DOI:https://doi.org/10.1111/trf.13090.

    Article  CAS  PubMed  Google Scholar 

  2. O. G. Kornilova, E. V. Paramonova, A. V. Nechaev, et al., Med. Immunol., 19(5), 513 – 520 (2017); DOI:https://doi.org/10.15789/1563-0625-2017-5-513-520.

    Article  Google Scholar 

  3. S. J. Thorpe, Transfusion, 55, S80-S85 (2015).

    Article  CAS  PubMed  Google Scholar 

  4. C. L. Bellac, D. Polatti, T. Hottiger, et al., Biologicals, 42, 57 – 64 (2014).

    Article  CAS  PubMed  Google Scholar 

  5. S. J. Thorpe, B. J. Fox, C. D. Dolman, et al., Biologicals, 33, 111 – 116 (2005).

    Article  CAS  PubMed  Google Scholar 

  6. European Pharmacopoeia EDQM, 8,5 Ed.; http: //online6.edqm.eu/ep801 /# (accessed Apr. 24, 2017).

  7. General Pharmacopoeial Monograph “Determination of anti-A and anti-B hemagglutinins in human immunoglobulin medicinal preparations” (GPM 1.8.2.0005.15); http: //pharmacopoeia.ru/[http: //pharmacopoeia.ru/ofs-1-8-2-0005-15-opredelenie-anti-a-i-anti-v-gemagglyutininov-v-lekarstvennyhpreparatah-immunoglobulinov / ] (accessed Apr. 24, 2017).

  8. S. J. Thorpe, B. Fox, G. Sharp, et al., Vox Sang., 97, 160 – 168 (2009); http: //onlinelibrary.wiley.com/doi/https://doi.org/10.1111/j.1423-0410.2009.01194.x/full[doi:https://doi.org/10.1111/j.1423-0410.2009.01194.x].

  9. General Pharmacopoeial Monograph “Determination of protein” (GPM.1.2.3.0012.15); http: //pharmacopoeia.ru/ofs-1-2-3-0012-15-opredelenie-belka / (accessed Apr. 24, 2017).

  10. S. Glantz, Primer of Biostatistics, McGraw-Hill, New York (1997).

    Google Scholar 

  11. RU Pat. Appl. No. 2017119536, 2017.

  12. Recommendations for the preparation, characterization and establishment of international and other biological reference standards, WHO Technical Report Series 932, annex 2, Geneva (2004), pp. 73 – 131.

  13. GOST 8.315–97, GSI, Certified reference materials for the composition and properties of substances and materials. Basic principles, Izd. Standartov, Moscow (2004).

Download references

Author information

Authors and Affiliations

  1. Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation, Moscow, 127051, Russia

    O. G. Kornilova, A. V. Nechaev, I. V. Borisevich & É. Yu. Kudasheva

Authors
  1. O. G. Kornilova
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. A. V. Nechaev
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. I. V. Borisevich
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. É. Yu. Kudasheva
    View author publications

    You can also search for this author in PubMed Google Scholar

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 51, No. 11, pp. 57 – 60, November, 2017.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Kornilova, O.G., Nechaev, A.V., Borisevich, I.V. et al. Standardization of the Method for Determining Hemagglutinin Content in Human Immunoglobulin Preparations in Russia. Pharm Chem J 51, 1041–1044 (2018). https://doi.org/10.1007/s11094-018-1736-2

Download citation

  • Received:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11094-018-1736-2

Keywords

Search

Navigation