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18F-FDG (Fluodeoxyglucose-18F injection)
[18F]FDG has become a common imaging modality in oncology. [18F]FDG is an analogue of glucose that contains the radionuclide Fluorine-18. This radiotracer provides valuable functional information based on the increased glucose uptake and glycolysis of cancer cells.
Fluorine-18 decays by positron (β+) emission and has a physical half-life of 109.7 minutes.
The quality requirements of [18F]FDG are set out in various pharmacopoeia including the USP, BP, EP…
Although there are some differences among these references, the philosophy and key analysis are similar and require the same analytical equipment.
Test |
Technique / instrument |
Appearance |
Visual |
Radionuclidic Identity |
Gamma-ray spectroscopy with a multichannel analyser (MUCHA) |
Radionuclidic Identity |
Half-life determination with a dose calibrator or alternative detector |
pH |
pH-meter or pH strips with reading through a reflexion photometer |
Chemical purity (Chloro-DG, FDG) |
Isocratic HPLC with a carbohydrate detector (PAD or RID) and a He purge |
Impurity kryptofix 222 (aminopolyether) |
Spot test (camera) |
Residual solvents (EtOH, CH3CN) |
Gas chromatography |
Bacterial endotoxins (LAL) |
Endosafe Portable Test System (nexgen PTS) |
Radiochemical purity |
Radio-HPLC |
Radiochemical purity |
Radio-TLC |
Radiochemical identity |
Radio-HPLC |
Osmolality ("not compulsory") |
Osmometer |
Radionuclidic purity |
Gamma-ray spectroscopy with a multichannel analyser (MUCHA) |
Sterility |
Compendial method |
Radioactivity, volumic activity |
Dose calibrator |