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Table 5: List of QC stability tests performed at the two production sites.

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

  0 h 3 h 6 h 9 h 12 h
Characters Visual control     Visual control
Identification MCA: Radionuclide identity [18F]fluoride     MCA: Radionuclide identity [18F]fluoride
Identification Radionuclide identity, T1/2     Radionuclide identity, T1/2
Identification HPLC: Chemical identity HPLC: Chemical identity HPLC: Chemical identity HPLC: Chemical identity HPLC: Chemical identity
Tests pH pH pH pH pH
Tests HPLC: FDG in product HPLC: FDG in product HPLC: FDG in product HPLC: FDG in product HPLC: FDG in product
Tests Spottest: Kryptofix     Spottest: Kryptofix
Tests GC: ethanol GC: ethanol GC: ethanol GC: ethanol GC: ethanol
Tests GC: acetonitrile GC: acetonitrile GC: acetonitrile GC: acetonitrile GC: acetonitrile
Tests Sterility Sterility Sterility Sterility Sterility
Tests Endotoxins     Endotoxins
Tests MCA: Radionuclide purity [18F]fluoride     MCA: Radionuclide purity [18F]fluoride
Tests TLC: Radiochemical purity [18F]FDG + [18F]FDM TLC: Radiochemical purity [18F]FDG + [18F]FDM TLC: Radiochemical purity [18F]FDG + [18F]FDM TLC: Radiochemical purity [18F]FDG + [18F]FDM TLC: Radiochemical purity [18F]FDG + [18F]FDM
Tests HPLC: [18F]FDM HPLC: [18F]FDM HPLC: [18F]FDM HPLC: [18F]FDM HPLC: [18F]FDM
Tests TLC: Other radiochemical impurities TLC: Other radiochemical impurities TLC: Other radiochemical impurities TLC: Other radiochemical impurities TLC: Other radiochemical impurities
Tests TLC: Radiochemical purity [18F]FDG + [18F]FDM TLC: Radiochemical purity [18F]FDG + [18F]FDM TLC: Radiochemical purity [18F]FDG + [18F]FDM TLC: Radiochemical purity [18F]FDG + [18F]FDM TLC: Radiochemical purity [18F]FDG + [18F]FDM
Tests MCA: Radionuclide purity 24h +     MCA: Radionuclide purity 24h +