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

From: Cyclotron-based production of 68Ga, [68Ga]GaCl3, and [68Ga]Ga-PSMA-11 from a liquid target

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