Table 4 Data from the PET centres in Tromsø and Trondheim and showing stability studies for [18F]FDG after 0, 3, 6, 9 and 12 hours EOS on average of three batches
Tests | Acceptance criteria | Results (Trond-heim) O h | Results (Tromsø) O h | Results (Trond-heim) 3 h | Results (Tromsø) 3 h | Results (Trond-heim) 6 h | Results (Tromsø) 6 h | Results (Trond-heim) 9 h | Results (Tromsø) 9 h | Results (Trond-heim) 12 h | Results (Tromsø) 12 h |
|---|---|---|---|---|---|---|---|---|---|---|---|
Characters Visual control | Clear, colourless or slightly yellow solution | Pass | Pass | Pass | Pass | ||||||
Identification MCA: Radionuclide identity [18F]fluoride | 511 keV ± 3%a1 | 513.4 ± 2.3 | 511.2 ± 1.7 | 512.4 ± 0.6 | 509.3 ± 0.9 | ||||||
Identification Radionuclide, T1/2 | 105–115 minutes | 110.0 ± 0.5 | 111.3 ± 1.5 | 109.4 ± 0.7 | 110.3 ± 0.6 | ||||||
Identification HPLC: Chemical identity | Rt FDG SST, the same as Rt for [18F]FDG | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass |
Tests pH | 4.55–8.45 | 5.7 ± 0.3 | 5.0 ± 0.2 | 5.6 ± 0.3 | 5.0 ± 0.2 | 5.5 ± 0.4 | 4.9 ± 0.2 | 5.6 ± 0.2 | 5.0 ± 0.2 | 5.5 ± 0.3 | 5.16 ± 0.1 |
Tests HPLC: FDG in product | < 25 µg/mLb | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Tests Spottest: Kryptofix | < 0.11 mg/mLb | Pass | Pass | Pass | Pass | ||||||
Tests Residual solvents GC: Ethanol | 2.5 mg/mLb | 1.53 ± 0.2 mg/mL | 1.42 ± 0.3 mg/mL | 1.68 ± 0.4 mg/mL | 1.42 ± 0.5 mg/mL | 1.63 ± 0.5 mg/mL | 1.40 ± 0.3 mg/mL | 1.64 ± 0.5 mg/mL | 1.53 ± 0.4 mg/mL | 1.61 ± 0.5 mg/mL | 1.36 ± 0.4 mg/mL |
Tests Residual solvents GC: Acetonitrile | 0.205 mg/mLb | < 0.103 mg/mL | < 0.064 mg/mL | < 0.103 mg/mL | < 0.064 mg/mL | < 0.103 mg/mL | 0.070 ± 0.01 mg/mL | < 0.103 mg/mL | 0.085 ± 0.04 mg/mL | < 0.103 mg/mL | 0.08 ± 0.03 mg/mL |
Tests Sterility | 0 CFU/mL | Sterile | Sterile | Sterile | Sterile | Sterile | Sterile | Sterile | Sterile | Sterile | Sterile |
Tests Endotoxins | < 8.75 EU/mLb | < 2.50 | < 2.50 | < 2.50 | < 2.50 | ||||||
Tests MCA Radionuclide purity [18F]fluoride | > 99.9% | 100% | 100% | 100% | 100% | ||||||
Tests HPLC: Radiochemical purity, [18F]FDG + [18F]FDM | > 95 % | 99.6 ± 0.004 % | 99.6 ± 0.025 % | 99.2 ± 0.001 % | 99.1 ± 0.180 % | 99.0 ± 0.002 % | 98.1 ± 0.936 % | 99.0 ± 0.003 % | 98.7 ± 0.494 % | 98.3 ± 0.003 % | 98.7 ± 0.7 |
Tests HPLC: [18F]FDM | < 10 % | 0% | 0% | 0% | 0% | 0% | 0.25 ± 0.388 | 0% | 0.053 ± 0.092 | 0 % | 0.08 ± 0.1 |
Tests TLC: Other radiochemical impurities | < 5% | 0.34 ± 0.006% | 0.36 ± 0.09% | 0.00 ± 0.00% | 0.13 ± 0.115% | 0.54 ± 0.009% | 0.28 ± 0.242% | 0.46 ± 0.008% | 0.8 ± 0.397% | 0.38 ± 0.007% | 0.5 ± 0.4 |
Tests TLC: Radiochemical purity [18F]FDG + [18F]FDM | > 95% | 99.7 ± 0,01% | 99.4 ± 0,41% | 100 ± 0.0% | 99.6 ± 0,39% | 99.5 ± 0.01% | 99.4 ± 0,49% | 99.5 ± 0.01 | 98.7 ± 0,74% | 99.4 ± 0.08% | 98.9 ± 0.7 |
Tests MCA: Radionuclide purity 24h + | > 99.9% | 99.981 ± 0.021 | 100% | 99.987 ± 0.004% | 100% |