Pharmaceutical grade sodium [99mTc] pertechnetate from low specific activity 99Mo using an automated 99Mo/99mTc-TCM-autosolex generator

Performance study of a computer controlled automated closed cyclic module for the separation and recovery of Tc-99m from low specific activity (n, gamma) Mo-99 using methyl ethyl ketone (MEK) solvent extraction technique named Mo-99/Tc-99m-TCM-AUTOSOLEX (Technetium automated solvent extraction) Generator is described. The entire system is automated and controlled by a user-friendly PC based graphical user interface that actually supervises process via an embedded system based electronic controller. The average yield of separation of Tc-99m was above 85 % and Mo-99 breakthrough in Tc-99m pertechnetate was < 0.002 %. The sodium pertechnetate obtained was a clear solution having pH 6-7, Radiochemical (RC). Purity > 99 %, MEK content < 0.1 % (v/v), Al and Mo content < 10 A mu g/ml. R. C. Purity of Tc-99m-radiopharmaceuticals studied was not less than 96 %. Bio-Quality control studies confirm that sodium pertechnetate obtained was sterile and pyrogen free. Imaging studies in animals and humans with limited radiopharmaceuticals show that the quality of Tc-99m-pertechenate obtained in the present module was good enough to do clinical study.