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Table 8 Quality Control Data for three [68Ga]Ga-PSMA-11 validation runs (UM)

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 (UM)
Radiochemical Purity (via TLC) 99.5 99.4 99.3 99.4 ± 0.1 ≥ 90%
Relative Retention time (via HPLC) 1.004 1.005 1.005 1.0046 ± 0.0003 RRT: 0.9–1.1
pH 7.0 7.0 7.0 7.0 4.0–8.0
Visual Inspection Passed Passed Passed N/A Clear, colorless, no visible particulate
Radionuclidic Identity (t½) 67.61 68.45 67.20 67.75 ± 0.53 64.6–71.4 min
Endotoxin Analysis <  2 <  2 <  2 <  2 ≤ 10.9 EU/mL
Bubble Point (PSI) 51 52 53 52 ± 1 ≥ 50 PSI
Sterility Passed Passed Passed Passed Complies with USP< 71>a
RNP at EOB (MCA) 99.8 99.8 99.8 99.8 ≥ 98% (at time of use)
  1. aSee: USP 71 Microbiological Tests/Sterility Tests 2012