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Table 1 Overview of selected [68Ga]GaCl3 productions with associated quality control results analysed according to draft Ph. Eur. monograph on accelerator produced gallium-68. Limits given by the draft Ph. Eur. monograph are shown in parentheses. ND: Not determined. WP: White precipitate. EOP: End of purification

From: Multi-curie production of gallium-68 on a biomedical cyclotron and automated radiolabelling of PSMA-11 and DOTATATE

Production run 1 2 3 4
Zinc-68 mass 315 mg 230 mg 240 mg 300 mg
Beam current & time 50 µA, 30 min 70 µA, 30 min 80 µA, 2 h 80 µA, 2 h
Charge (µAh) 25 36.2 163.4 164
GBq@EOP 37 51 152 194
Appearance (Clear & colorless) C&C C&C C&C C&C
γ-Spectrometry (Confirmed ID by 511 & 1077 keV) Confirmed Confirmed ND Confirmed
T½ (62―74 min.) 66.2 71.2 66.4 67.1
Solid Phase Extraction (> 90% of total radioactivity) 91.3% 95.0% ND 93.8%
Precipitation with AgNO3 WP WP WP WP
pH (< 2)  < 2  < 2  < 2  < 2
Contents of Fe (< 10 µg/GBq) 0.037 µg/GBq 0.0077 µg/GBq 0.0074 µg/GBq 0.0036 µg/GBq
Contents of Zn (< 10 µg/GBq) 0.36 µg/GBq 0.85 µg/GBq 0.18 µg/GBq 0.058 µg/GBq
Bacterial endotoxins (< 175 IU/ V)  < 1.75 IU/mL  < 2 IU/mL ND  < 1.85 IU/mL
γ-Spectrometry (> 98% Ga-68) 99.95% 99.89% 99.85% 99.97%
Contents of Ga-66/67 (< 2%) 0.047% 0.11% 0.15% 0.029%
Other radionuclidic impurities (< 0.1%) Not detected Not detected Not detected Not detected
TLC (> 95% Ga3+) 100% 99.9% 100% (@ + 24 h) 99.9%