The substantiation of the quality control method for determining the radionuclide purity and the total radioactivity of radiopharmaceuticals
Keywords:quality control, radiopharmaceuticals, radionuclide calibrator for nuclear medicine, radionuclide purity, radioactivity
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”.
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