18F-DOPA

[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.

The principal tests for [18F]-Dopa are:

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

Radiochemical identity

Radio-HPLC

Osmolality (not compulsory)

Osmometer

Radionuclidic purity

Gamma-ray spectroscopy with Multichannel analyser

Sterility

Compendial method

Radioactivity

Dose calibrator