Quality assurance and quality control methods for animal and human applications of no-carrier-added 6-[18F]fluorodopa for PET investigations of dopaminergic systems

  • Appl Radiat Isot. 1993 Jul;44(7):993-8. doi: 10.1016/0969-8043(93)90001-q.
G N Reddy  1 ,  M Haeberli ,  H F Beer ,  P Hasler ,  A P Schubiger
Affiliations
  • 1. Division of Radiopharmacy, Paul Scherrer Institute, Villigen PSI, Switzerland.
PMID: 8339075 DOI: 10.1016/0969-8043(93)90001-q
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.

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