Continuation of comprehensive quality control of the itG 68 Ge/ 68 Ga generator and production of 68 Ga-DOTATOC and 68 Ga-PSMA-HBED-CC for clinical research studies.

UNLABELLED: Performance of a second itG 68 Ge/68 Ga generator system and production of 68 Ga-DOTATOC and 68 Ga-PSMA-HBED-CC were tested over one year as an accompaniment to a previously published study (J Nucl Med. 2016;57:1402-1405).

METHODS: Performance of a 1951MBq 68 Ge/68 Ga generator was characterized and the eluate used for preparation of 68 Ga-DOTATOC and 68 Ga-PSMA-HBED-CC. Weekly elution profiles of 68 Ga elution yield and 68 Ge breakthrough were determined.

RESULTS: 68 Ga elution yields averaged 82% (61.8-98.4%) and 68 Ge breakthrough averaged 0.002% (0.0007% to 0.004%). The radiochemical purities of 68 Ga-DOTATOC and 68 Ga-PSMA-HBED-CC were determined by HPLC analysis to be >98% and specific activity was 12.6 and 42GBq/μmol, respectively. 68 Ge contamination in the product was under the detection limit (0.00001%). Final sterile, pyrogen-free formulation of 68 Ga-DOTATOC and 68 Ga-PSMA-HBED-CC in physiologic saline with 5%-7% ethanol was achieved.

CONCLUSION: Performance of a 68 Ge/68 Ga generator was studied over one year with satisfactory results. The generator eluate was used to synthesize 68 Ga-DOTATOC and 68 Ga-PSMA-HBED-CC on a routine basis in high purity.