Evaluation of radiochemical purities of some radiopharmaceuticals in Shiraz Namazi teaching hospital

Many radiopharmaceuticals, as a special group of drugs, are eventually prepared at the nuclear medicine departments of the hospitals. Therefore, their qualitycontrol procedures such as sterility tests, radionuclide, radiochemical and chemical purity should be carried out in the hospitals. In this study, radiochemical purityfor more than 300 preparations of three different radiopharmaceutical formulations from commercial kits were tested using instant thin layer chromatography.The formulations 99mTc-DTPA, 99mTc-MDP and 99mTc-MIBI were obtained from Pars Isotope Co. Several paper chromatographic systems includingstandard and factory recommended thin layer chromatography systems were used in this study. In addition different equipments for detection of radioactivity in paper chromatography like gamma camera and dose calibrator were used. The results showed that themost observed impurities were hydrolyzed reduced technetium (HR-Tc). There were no significant differences between calculated 99mTc-MIBI radiochemicalpurities when the radioactive detection device was gamma camera instead of dose calibrator. In case of 99mTc-DTPA and 99mTc-MDP, there were significant differences in detection of HR-Tc. On the contrary, no significant differences in free pertechnetate wereobserved when package insert procedures for quality control were used instead of those recommended in the references. Finally, we observed that the package insert procedures for quality

Keywords:

Quality control , Instant Thin Layer Chromatography , Radiopharmaceuticals , 99m Technetium , 99mTc-MIBI , 99mTc-DTPA , 99mTc-MDP , HR-99mTc