Table 7.

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

TEST	1	2	3	Avg & SD	Release Criteria (Ph. Eur.)
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 Bb (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 (t½)	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)

^aAfter FASTLab isolation; ^b Reference solution B (Pentetic acid solution) from the European Pharmacopoeia (Gallium (⁶⁸Ga) chloride (accelerator-produced) solution for radiolabeling 2020)