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Adaptaci贸n del m贸dulo de 18FDG para la preparaci贸n de una disoluci贸n inyectable de [18F] fluoruro s贸dico de conformidad con la Farmacopea Americana (USP聽32) y Europea (PhEur聽6)
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摘要

Objective

To establish an automated procedure for the preparation of sodium fluoride 18F injection using the resources available in our laboratory for the preparation of 18FDG and to analyze the repercussion of the conditioning column of the fluoride ion entrapment on the characteristics of the final product.

Material and method

The sequence of an 18FDG 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聽32 and EurPh聽6, adding control of ethanol levels of residual solvent and quality controls of the solution at 8聽h post-preparation.

Results

Activation of the resin cartridges with ethanol and water was the chosen procedure, with fluoride ion trapping >聽95%and pH around聽7. Ethanol levels were <聽5.000聽ppm. Quality controls at 8聽h indicated that the solution was in compliance with the USP聽32 and EurPh聽6 specifications.

Conclusion

This is an easy, low-cost, reliable automated method for sodium fluoride preparation in PET facilities with existing equipment for 18FDG synthesis and quality control.

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