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