Test results

Note: all applicable limits are calculated to V=10 mL

Parameter, substance LL UL Unit Measured Unit Result
Identification 2-[18F]fluoro-2-deoxy-D-glucose
ID by initial gamma-ray spectrometry 0.511 MeV 0.511 MeV pass
ID by R(t) of principal HPLC peak 7.7 7.9 min 7.8 min pass
ID by half-life 105 115 min 108 min pass
Appearance
clear clear pass
colorless or slightly yellow colorless pass
Tests and impurities
pH 4.5 8.5 6.2 pass
2-fluoro-2-deoxy-D-glucose 50 mg/L 0.75 mg/L pass
2-chloro-2-deoxy-D-glucose 50 mg/L 0.75 mg/L pass
Aminopolyether 220 mg/L < 10 mg/L pass
Residual solvents
Acetonitrile (class 2) 410 mg/L 0.4 mg/L pass
Ethanol (class 3) 5000 mg/L 19 mg/L pass
2-Propanol (class 3) 5000 mg/L n.d. mg/L pass
Methanol (class 2) 3000 mg/L 2 mg/L pass
Sterility sterile pass
Bacterial endotoxins 17.5 IU/mL 3 IU/mL pass
Gamma ray spectrometry
Test A: photon energy 0.511 MeV 0.511 MeV pass
Test B: radionuclidic impurities < 0.1 % < 0.02 % pass
Sample retained for > 24 h 24:19:36 hh:mm:ss
Radiochemical purity
[18F]fluoride and acetylated FDG derivatives < 5 % 0.3 % pass
Radioactivity from [18F]FDG and [18F]FDM > 95 % 98.5 % pass
[18F]FDM < 10 % 1.2 % pass
Other tests
Osmolality 270 315 mOsmol/L 305 mOsmol/L
Radioactivity concentration at reference time 985 MBq/mL