Quality assurance and quality control methods for animal and human applications of no-carrier-added 6-[18F]fluorodopa for PET investigations of dopaminergic systems
| Autor: | Guvvala N. Reddy, August P. Schubiger, P. H. Hasler, Hans-Frieder Beer, Marc Haeberli |
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| Rok vydání: | 1993 |
| Předmět: |
Quality Control
Fluorine Radioisotopes Radiation Quality Assurance Health Care business.industry Chemistry 18f fluorodopa media_common.quotation_subject Dopaminergic No carrier added Radiochemistry Dihydroxyphenylalanine Animals Humans Quality (business) business Enantiomeric excess Nuclear medicine Tomography X-Ray Computed Quality assurance Control methods Injectable Solution media_common |
| Zdroj: | Applied radiation and isotopes : including data, instrumentation and methods for use in agriculture, industry and medicine. 44(7) |
| ISSN: | 0969-8043 |
| Popis: | No-Carrier-Added (NCA) 6-[ 18 F]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. |
| Databáze: | OpenAIRE |
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