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Table 9 Quality Control Data for three [68Ga]Ga-PSMA-11 validation runs (RPA)

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

Tests 1 2 3 Avg & SD Release Criteria (RPA)
Radiochemical Purity (via TLC) 99.94 99.99 99.94 99.96 ± 0.03 ≥ 95%
Radiochemical Purity (via HPLC) 99.94 99.97 100.0 99.97 ± 0.03 ≥ 95%
pH 5.0 5.5 5.5 5.3 ± 0.3 4.0–8.0
Visual Inspection Passed Passed Passed N/A Clear, colorless, no visible particulate
Radionuclidic Identity (t½) 67.9 68.1 67.7 67.9 ± 0.20 62–74 min
Endotoxin Analysis <  1 <  1 <  1 <  1 ≤ 17.5 EU/mL
Bubble Point (bar) 4.1 4.2 4.1 4.1 ± 0.06 ≥ 3.5 bar
Sterility Passed Passed Passed Passed Sterile – no growth
RNP at EOS (Well Counter) 99.7 99.8 99.8 99.8 ± 0.06 ≥ 98% (at time of use)