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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

From: Stability evaluation of [18F]FDG: literature study, stability studies from two different PET centres and future recommendations

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%
  1. aPET Centre in Tromsø 511 KeV ± 5%
  2. bBased on 20 mL maximum volume