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

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%