Speaker
Description
Abstract
Most radiopharmaceuticals are used for the purpose of medical diagnosis. These radiopharma-ceuticals contain small amount of the active substances with a radionuclide attached to them to allow scintigraphic imaging or measurement of biodistribution. Radiation is a general prop-erty of all radiopharmaceuticals, which when administered give the patient an imminent radia-tion dose. Quality control (QC) tests are mandatory for radioactive drugs which are intended for human administration [1]. The safety and efficacy of radiopharmaceuticals are important factor of the quality assurance protocol. QA in radiopharmacy is critical for practice. A poor-quality diagnostic radiopharmaceutical, while not in itself unsafe, it could give incorrect in-formation about the patient’s condition leading to an inappropriate choice of therapy [2]
In this study a considerable number of DMSA, PYP, MAG-3, DTPA and HMPAO radio-pharmaceuticals samples are analyzed for their radiochemical purity using radiochemical puri-ty standard procedure. These products used in nuclear medicine Department of University Hospital Centre “Mother Theresa” and some private clinics in Albania are collected and tested for 5 years period. The aim of the work is to present the results for their radiochemical purity and to emphasize the need for the radiopharmaceutical quality control. The mean radiochemi-cal purity was 96.94% (standard deviation 7.82%) and 4.52% of all tested preparations failed to meet radiochemical preparation limits.
Keywords: radiopharmaceutical, quality control, radiochemical purity, radiation.
References
[1] Gopal Saha, “Fundamentals of Nuclear Pharmacy”, pp.163-183, 2018, DOI:10.1007/978-3-319-57580-3_8
[2] Ayfer Yurt Kılçar “Quality Assurance and Quality Control Methods in Radiopharmacy”, Nucl Med Semin 2023;9(1):76-83 DOI:10.4274 / nts.galenos.2023.0010