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Table 3 Results of synthesis and quality control tests for [18F]PSMA-1007 injection solution

From: Automated [18F]PSMA-1007 production by a single use cassette-type synthesizer for clinical examination

Test items Acceptance criteria Lot No.1 Lot No.2 Lot No.3
Activity yields (MBq) - 7,580 8,570 7,690
Appearance Clear and colorless Clear and colorless Clear and colorless Clear and colorless
Particle None None None None
Identity of
[18F]PSMA-1007 (min)
RT of PSMA-1007
+ 0.3–+ 0.7
+ 0.4 + 0.4 + 0.4
Half-life (min) 105–115 110 110 109
Concentration of activity yields (MBq/mL) > 18.5 610.7 667.5 621.5
Ethanol (v/v %) < 10.0 7.8 7.9 7.9
Residual MeCN (ppm) < 410 < 10 < 10 < 10
Residual DMSO (ppm) < 5,000 < 138 < 138 < 138
PSMA-1007 (μg/mL) < 10 0.5 0.8 0.7
(Molar activity (GBq/μmol)) - 1,204 829 907
Highest single chemical impurity (μg/mL) < 10 0.7 0.9 1.0
Total chemical impurities + PSMA-1007 (μg/mL) < 50 2.7 3.1 3.2
TBA (μg/mL) < 260 < 26 < 26 < 26
Radionuclidic identity Exhibits the peak at 511 keV Exhibits the peak at 511 keV Exhibits the peak at 511 keV Exhibits the peak at 511 keV
Radiochemical purity (at EOS) (%) > 95 98 97 98
[18F]Fluoride (at EOS) (%) < 5 < 5 < 5 < 5
Radiochemical purity
(6 h after EOS)
> 95 97 97 98
[18F]Fluoride (6 h after EOS) < 5 < 5 < 5 < 5
Radionuclidic purity Exhibits no peak except 511 keV and 1022 keV Exhibits no peak except 511 keV and 1022 keV Exhibits no peak except 511 keV and 1022 keV Exhibits no peak except 511 keV and 1022 keV
pH 4.5–8.5 6.6 6.7 6.7
Sterility Sterile Sterile Sterile Sterile
Endotoxin (EU/mL) < 15.0 < 2.0 < 2.0 < 2.0
Filter integrity test (kPa) > 286 318 317 327
  1. EOS end of synthesis
  2. RT retention time