Table 7 Quality Control Data for three [⁶⁸Ga]GaCl₃ validation runs (UM)^a

Radiochemical Purity [⁶⁸Ga]GaCl₃ (iTLC-SG)

99

98

98

98.3 ± 0.3

≥ 95

Rf [⁶⁸Ga]GaCl₃ (TLC)

<  0.2

<  0.2

< 0.2

<  0.2

≤ 0.2

Rf Ref B^b (TLC)

>  0.7

>  0.7

>  0.7

>  0.7

≥ 0.7

pH

<  2

<  2

<  2

<  2

<  2

Visual Inspection

Passed

Passed

Passed

N/A

Clear, colorless, no visible particulate

Radionuclidic Identity (t_½)

67.2

68.8

69.1

68.4 ± 0.8

64.6–71.4 min

Endotoxin Analysis

<  2

<  2

<  2

<  2

≤ 58.3 EU/mL

Fe μg/GBq

< 5

< 5

< 5

< 5

≤ 10 μg/GBq

Zn μg/GBq

< 1.25

< 1.25

< 1.25

< 1.25

≤ 10 μg/GBq

RNP at EOB (MCA)

99.8

99.8

99.8

99.8

≥ 98% (at shelf-life)