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Quality Control Procedure for 6-[¹⁸F]Fluoro-L-DOPA: A Presynaptic PET Imaging Ligand for Brain Dopamine Neurons

Clinical Brain Imaging Section, Laboratory of Cerebral Metabolism, National Institute of Mental Health, Cyclotron Facility and Radiopharmacy, Nuclear Medicine, Clinical Center, and Laboratory of Chemistry, National Institute of Diabetes and Digestive and Kidney Disease, National Institutes of Health, Bethesda, Maryland

Correspondence: For reprints contact: C. C. Chiueh, NIH, Bldg. 10, Rm. 2D-52, Bethesda, MD 20892-1000.

ABSTRACT

The goal of the current study was to establish a quality control procedure for clinical use of 6-[¹⁸F]fluoro-L-DOPA (6-[¹⁸F]-DOPA) as a selective presynaptic positron emission tomographic (PET) imaging ligand for brain dopamine neurons. A high performance liquid chromatographic procedure using a 5-µ C-18 reverse phase column and ion-pairing mobile phase was used for the quantification of 6-[¹⁸F]-DOPA. The radiochemical purity of 6-[¹⁸F]-DOPA was measured by ¹⁸F radioactivity in HPLC fractions while the chemical purity was determined by an amperometric electrochemical detector with a sensitivity of 25 pg. Quality control of eight consecutive batches of highly purified 6-[¹⁸F]-DOPA sample used in a pre-clinical trial revealed that the chemical and/or radiochemical purity of the PET imaging ligand, 6-[¹⁸F]-DOPA was greater than 97 ± 0.5% with a specific activity of 365 ± 31 mCi/mmol. The knowledge and assurance of radiochemical purity of PET ligands are essential for the interpretation of clinical PET imaging results. The assurance of such quality control would enable comparisons of 6-[¹⁸F]-DOPA/PET data obtained from various medical centers using different radiopharmaceutical procedures.