title: [Adaptation of the (18)FDG module for the preparation of a sodium fluoride [(18)F] injection solution in agreement with the United States (USP 32) and European Pharmacopeia (PhEur 6)].
abstract: OBJECTIVE
  To establish an automated procedure for the preparation of sodium fluoride (18)F injection using the resources available in our laboratory for the preparation of (18)FDG and to analyze the repercussion of the conditioning column of the fluoride ion entrapment on the characteristics of the final product.
  
  
  METHODS
  The sequence of an (18)FDG synthesis module prepared so that it traps the fluoride ion from the cyclotron in ion-exchange resin diluted with 0.9% sodium chloride. The final solution was dosified and sterilized in a final vial in an automatized dispensing module. Three different column conditioning protocols within the process were tested. Quality controls were run according to USP 32 and EurPh 6, adding control of ethanol levels of residual solvent and quality controls of the solution at 8 h post-preparation.
  
  
  RESULTS
  Activation of the resin cartridges with ethanol and water was the chosen procedure, with fluoride ion trapping > 95% and pH around 7. Ethanol levels were < 5.000 ppm. Quality controls at 8 h indicated that the solution was in compliance with the USP 32 and EurPh 6 specifications.
  
  
  CONCLUSIONS
  This is an easy, low-cost, reliable automated method for sodium fluoride preparation in PET facilities with existing equipment for (18)FDG synthesis and quality control.
authors.affiliation: Unidad de Radiofármacos PET, Hospital Clínico Universitario, Santiago de Compostela, España. mteresa.martinez5@carm.es
authors.forename: T
authors.initials: T
authors.lastname: Martínez
authors.forename: B
authors.initials: B
authors.lastname: Cordero
authors.forename: S
authors.initials: S
authors.lastname: Medín
authors.forename: A
authors.initials: A
authors.lastname: Sánchez Salmón
mesh_terms: D001331:Automation; D002852:Chromatography, Ion Exchange; D017357:Cyclotrons; D000431:Ethanol; D005060:Europe; D005462:Fluorine Radioisotopes / Q000737:chemistry*; D019788:Fluorodeoxyglucose F18 / Q000138:chemical synthesis* / Q000592:standards; D006863:Hydrogen-Ion Concentration; D007267:Injections; D007553:Isotope Labeling / Q000379:methods* / Q000592:standards; D010602:Pharmacopoeias as Topic / Q000592:standards*; D049268:Positron-Emission Tomography; D011786:Quality Control; D019275:Radiopharmaceuticals / Q000138:chemical synthesis* / Q000592:standards; D012965:Sodium Chloride / Q000737:chemistry; D012969:Sodium Fluoride / Q000138:chemical synthesis*; D012997:Solvents; D014481:United States; D014867:Water
chemical_list: D005462:Fluorine Radioisotopes; D019275:Radiopharmaceuticals; D012997:Solvents; D014867:Water; D019788:Fluorodeoxyglucose F18; D000431:Ethanol; D012965:Sodium Chloride; D012969:Sodium Fluoride