As before, special attention is paid to improving the qualitative and quantitative indicators of the Federal Center for the Control of Microbiology of FMBA of Russia, on the basis of which the project "Development of analytical control methods for experimental drugs for radionuclide diagnostics of PET" is being implemented.
“With the support of the Government of the Ulyanovsk Region, we were able to supply modern specialized equipment - a miniGITA Star Positron Raytest-Elysia thin-layer chromatography scanner, for projects of the Federal Center for the Measurement of Mass Media. This will allow significant progress in organizing the production of radiopharmaceuticals. Also, this equipment will be used by the supporting higher education institution of the region - UlSU with the goal of introducing scientific developments aimed at creating new radiopharmaceuticals, ”said Rustem Davlyatshin, deputy director CDC.
According to experts, this type of equipment is the best choice for the PET center of the Center. Already today, work on it allows us to solve a number of problems in determining the radiochemical purity of synthesized radiopharmaceuticals.
Head of the division of the cyclotron-radiochemical complex of radionuclide support of the PET center A. Egorova focused on the benefits of using this device.
“Using this device, quality control of the produced radiopharmaceutical will be carried out much faster and more efficiently, which will reduce the waiting time for delivery of the radiopharmaceutical to the patient. At the same time, the quality of the study improves and it becomes possible to examine a larger number of patients, ”said Anna Egorova.
For reference. Today, the start-up phase is the production of fluorodeoxyglucose based on the fluorine-18 isotope, in the future it is planned to expand the line of preparations based on carbon-11, galium-68, lutetium-177. To confirm the quality of the preparations, it is necessary to carry out a series of analyzes of various parameters; to equip the quality control laboratory, a TLC scanner is required, which determines the most important parameter, the radiochemical purity of any manufactured preparation. The radiochemical purity of the drug is a characteristic of the radionuclide composition of the radioactive drug. A preparation is called radiochemically pure (RCP) if it does not contain any impurities of radionuclides of elements other than this one. Radiochemical purity is the ratio of the activity of a radionuclide that is present in a preparation in the declared chemical form of a basic substance to the total activity of a radionuclide in this preparation, expressed as a percentage. Therefore, for an operative and accurate analysis, a device with certain parameters and characteristics is needed that allows the study of the drug in a short time. The determination of radiochemical purity is one of the fundamental factors in issuing conclusions about the quality of the produced drug and it is it that is reflected in the Quality Certificate of the radiopharmaceutical transferred to the doctor for patients.