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Table 2 Results of the automated clinical productions of [18F]Ga-rhPSMA-7/ -7.3 and corresponding quality control data

From: Automated synthesis of [18F]Ga-rhPSMA-7/ -7.3: results, quality control and experience from more than 200 routine productions

Results and Quality Control
Overall productions 243
Successful productions 240 (98.8%)
Failed productions 3* (1.2%)
Productions with minor deviation from specification 4** (1.6%)
Radiochemical Yield [%] 49.2 ± 8.6
Product Activity [GBq] 43.6 ± 9.3
Molar Activity [GBq/μmol] 290.9 ± 62.1
Volume [mL] 17.7 ± 1.2
Radioactive Concentration [MBq/mL] 2410.2 ± 472.9
Radiochemical Purity by HPLC [%] 99.94 ± 0.23
Radiochemical Purity by TLC [%] 97.84 ± 0.95
Residual Solvents  
Ethanol [mg/mL] 52.0 ± 10.0
Acetonitrile [μg/mL] 40.1 ± 21.6
DMSO [μg/mL] 130.7 ± 79.3
Kryptofix® (< 50 μg/mL) below limit
Endotoxins [EU/mL] <  2.5
Sterility passed
  1. *RCP < 90% by radio-TLC (n = 2); technical problem of the dispenser (n = 1)
  2. **RCP = 93.1–94.3% by radio-TLC; specification: RCP ≥ 95.0%; batches were released