title: Quality assurance and quality control methods for animal and human applications of no-carrier-added 6-[18F]fluorodopa for PET investigations of dopaminergic systems.
abstract: No-Carrier-Added (NCA) 6-[18F]fluoro-L-dopa (6-FDOPA) is being produced routinely for PET investigations of dopaminergic systems at our Institute. We describe here in detail the quality assurance methods involved in its multi-step developmental stage as a radiopharmaceutical. A method to remove toxic copper ions to prepare an injectable solution is described. The stability and shelf-life of NCA 6-FDOPA was also examined and results are discussed. Quality control involved three major aspects: (a) chemical purity, (b) radiochemical purity and (c) enantiomeric excess. A method for quick quality control of individual batch preparations is described.
authors.affiliation: Division of Radiopharmacy, Paul Scherrer Institute, Villigen PSI, Switzerland.
authors.forename: G N
authors.initials: GN
authors.lastname: Reddy
authors.forename: M
authors.initials: M
authors.lastname: Haeberli
authors.forename: H F
authors.initials: HF
authors.lastname: Beer
authors.forename: P
authors.initials: P
authors.lastname: Hasler
authors.forename: A P
authors.initials: AP
authors.lastname: Schubiger
mesh_terms: D000818:Animals; D004295:Dihydroxyphenylalanine / Q000031:analogs & derivatives* / Q000138:chemical synthesis; D005462:Fluorine Radioisotopes; D006801:Humans; D011785:Quality Assurance, Health Care; D011786:Quality Control; D014057:Tomography, X-Ray Computed
chemical_list: D005462:Fluorine Radioisotopes; C043437:fluorodopa F 18; D004295:Dihydroxyphenylalanine