[Long-term Quality Control Test of a 68Ge/68Ga Generator].

Abstract

Quality of the ⁶⁸Ga solution eluted from a ⁶⁸Ge/⁶⁸Ga generator (Galli Eo^®) was evaluated. Elution was performed 488 times from 21 to 484 days (ca. 15 months) after the calibration date. The eluted ⁶⁸Ga activity was 329 MBq to 1,148 MBq, which decreased with the decay of ⁶⁸Ge, but no significant change was observed in the elution yields (62.8±2.2%). The half-life of the eluted radioactivity was 67.8±0.1 min, the radionuclide purity of ⁶⁸Ga was ≥99.9%, the ⁶⁸Ge breakthrough was 0.000024 ±0.000004%, and the radiochemical purity of ⁶⁸Ga³⁺ was 99.7±0.2%. Fe and Zn were detected as metal impurities in the eluent, but both were ≤10 μg/GBq. The endotoxin concentration of the eluate was ≤5 EU/mL, and the eluent passed the sterility test. These results show that the generator can stably provide ⁶⁸Ga solution over a 15-month period.