The substantiation of the quality control method for determining the radionuclide purity and the total radioactivity of radiopharmaceuticals

Authors

  • V. V. Kachaniuk Ukrainian military medical academy, Ukraine
  • V. M. Shevel Institute of Nuclear Research of the National Academy of Sciences of Ukraine, Ukraine

DOI:

https://doi.org/10.24959/nphj.20.15

Keywords:

quality control, radiopharmaceuticals, radionuclide calibrator for nuclear medicine, radionuclide purity, radioactivity

Abstract

The quality control in the manufacture of radiopharmaceuticals has a prominent role in providing the supply of high-quality drugs for the diagnosis and treatment of patients with cancer. It has been determined that the permission to use radiopharmaceuticals directly depends on the results of the analytical control.
Aim. To reduce the time for the quality control of radiopharmaceuticals, resulting in both the radiochemical yield of the product and its specific activity. This is an important parameter in conducting diagnostic or therapeutic procedures.
Materials and methods. To optimize the process of the quality control for radiopharmaceuticals we propose to replace the following laboratory equipment: a Moleculer Mol gamma spectrometer, which monitors the radionuclide purity of radiopharmaceuticals (gamma-ray energy measurement) and a BIODEX ATOMLAB 500 preloaded device (measurement of the total radioactivity of a drug) to a radionuclide calibrator for nuclear medicine developed by domesti scientists of the Institute of Scintillation Materials and made at the “Kvant” X-ray equipment plant in Kharkiv.
Results and discussion. It has been proven that the use of calibrator radiopharmaceuticals for nuclear medicine should be applied as the quality control. It has been substantiated that the calibrator of doses for nuclear medicine performs two functions simultaneously.
Conclusions. The method of optimization of the quality control of radiopharmaceuticals using the device – a radionuclide calibrator for nuclear medicine allows us to simultaneously obtain the results of the analysis by such indicators as “radionuclide purity” and “radioactivity”.

Author Biographies

V. V. Kachaniuk, Ukrainian military medical academy

senior teacher of the Department of Military Pharmacy

V. M. Shevel, Institute of Nuclear Research of the National Academy of Sciences of Ukraine

deputy chief engineer of the Department of Research Nuclear Reactor

References

Nastanova ST–N MOZU 42–3.5:2016. (2016). Likarski zasoby. Nalezhna vyrobnycha praktyka. Vydannia ofitsiine. Kyiv: Ministerstvo okhorony zdorovia Ukrainy,120.Radionuklidnyi kalibrator dlya yadernoyi medytsyny: pat. 60782 Ukrayina: MPK (2011.01), G01T 1/00; 25.06.2011.

Pat. 60782 Ukraina: MPK (2011.01), G01T 1/00. (2011). Radionuklidnyi kalibrator dlia yadernoi medytsyny.

Pat. 86967_2 Ukraina. (2014). Sposib promyslovoho vyrobnytstva ekstraktsiinoho tekhnetsiiu 99M.

Derzhavna farmakopeia Ukrainy. (2–edition). (2018). Radiofarmatsevtychni likarski zasoby, 1047–1053. Nakaz Ministerstva okhorony zdorov’ia Ukrainy №476 vid 14.03.2018 r.

Semeniv, I. P., Kmetiuk, Ya. V., Moskalets, O. I. (2013). Promeneva diahnostyka. Promeneva terapiia, 2–3, 88–92.

Kachaniuk, V. V., Trokhymchuk, V. V., Sarychev, S. Yu. (2017). Farmatsevtychnyi zhurnal, 1, 51–58.

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Published

2020-01-27

Issue

No. 1(99) (2020)

Section

Synthesis and Analysis of Biologically Active Substances

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