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

EJNMMI Radiopharmacy and Chemistry

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

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

^*RCP < 90% by radio-TLC (n = 2); technical problem of the dispenser (n = 1)
^**RCP = 93.1–94.3% by radio-TLC; specification: RCP ≥ 95.0%; batches were released