An assay on the quality of thallous chloride radiopharmaceutical produced in atomic energy organization of Iran

Introdution . Thall ous chloride (TI-201) radiopharmaceutical is routinly used for heart imaging in nuclear medicine departments. The goal of this project was to study the quality of TI-201 radioph armaceuticals produced in cyclotron department of atomic energy organization of Iran according to European and United States standards. Materials and Methods. This radiopharmaceuti cal was produc ed in 15 stages thro ugh 2°'TI (p,3n) 201 Pb ~ZOl TI nuclear reaction in which the inciden t pro ton energy is 28 Mev. Radionuclidic impurities (ZO'Ph, zo"TI, 2O'TI) were det ermin ed by gamma-spectrometer with high pure Ge (HPGe) detector for production and pre -calibration dates and for one 20lTI half life (73.5 hr) later. The radiochemical impurity (TP+ in comparison to TI+), specific activity and activity distr ibution in vials were determined by electrophoresis, polarography and gamma spectrometry, and dose calibra tor , respectively. Results. In fifthteen production stages radionuclidic and radiochemical purity of product and it's specific activity have been higher than 97%, 95%, and 3.7 GBq/mg-TI resp ectively But in three stages zo'Pb impurity has been higher than 0.3% determined in USP. Accuracy of activity distribution in vials was higher than 10% in all stages. Conclusion. The results show that the product quality is in accordance to the British and Euro pean standards (BP and EP). In accordance to the United States Pharmacopoeia (USP), although in three stages of fifthteen production stages 2°'Pb impurity has been higher than 0.3% determined in USP, radio nuclidic purity has bee n acceptable (>99%).