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[18F]-FDOPA (6-[18F]--Fluoro-L-DOPA, FluoroDOPA (18F) injection)
The [18F]-radiolabeled amino acid 3,4-dihydroxy-6-18F-fluoro-L-phenylalanine ([18F]--DOPA) has been used for over 30 years to image the presynaptic dopaminergic system in the human brain in order to investigate a number of CNS disorders, in particular schizophrenia. Subsequently, other clinical applications have arisen, beginning in the field of oncology (brain tumors and neuroendocrine tumors, Pretze.M. BioMed Research International, Volume 2014 (2014)).
The development of nucleophilic introduction of the fluoride-18 anion during the last years improves drastically the availability of this tracer among PET centres.
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Test |
Technic/instrument |
|
Appearance |
Visual |
|
Radionuclidic Identity |
Gamma-ray spectroscopy with 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 (6-Fluorolevodopa, dopa and related substances) |
Gradient HPLC with UV detector |
|
Enantiomeric purity |
Isocratic HPLC with UV detector |
|
Impurtiy kryptofix (aminopolyether) |
Spot test |
|
Residual solvents |
Gas chromatography |
|
Bacterial endotoxins (LAL) |
Endosafe Portable Test System (PTS) |
|
Radiochemical purity |
Radio-HPLC (isocratic with UV detector) |
|
Radiochemical purity [18F]-fluoride, 6-[18F]-fluorodextrodopa |
Radio-TLC |
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Radiochemical identity |
Radio-HPLC |
|
Osmolality (not compulsory) |
Osmometer |
|
Radionuclidic purity |
Gamma-ray spectroscopy with Multichannel analyser |
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Sterility |
Compendial method |
|
Radioactivity |
Dose calibrator |