Development of an in-house method for the synthesis of Sodium [18F]fluoride preparation

Atanasova, Marija and Kolevska, Katerina and Cocevska, Maja (2023) Development of an in-house method for the synthesis of Sodium [18F]fluoride preparation. In: International Symposium on Trends in Radiopharmaceuticals (ISTR-2023), 17-21 Apr 2023, Vienna.

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Abstract

Sodium [18F]fluoride is PET radiopharmaceutical containing fluorine-18 in the form of sodium fluoride.
Aim: To develop an in-house method for [18F]NaF production using only a dispensing module for both, radiopharmaceutical synthesis and dose dispensing.
Material and methods: The semi-automatic dispenser for radiopharmaceuticals with a single-use sterile disposable kit (Clio, Comecer) was used. The kit includes four three-way valves, lines for different purposes, and a 0.22 µm sterilization filter. For the production of [18F]NaF, we made a modification of the kit. On the first valve, we installed a Sep-Pak Accell Plus QMA cartridge, Y connector, and sterile vial with 0.9% sodium chloride. The preconditioned QMA cartridge was connected to the distal part of the Y connector and attached to the first valve of the kit. One proximal ending of the Y connector was connected to the [18F]F- cyclotron transfer line and the other proximal ending to the vial with 5 mL 0.9% NaCl for elution. Results: After the development of our in-house method for synthesis, the process optimization was carried out, 10 production batches were performed, with a yield higher than 98%, decay-corrected.
Conclusion: The quality control results confirm that the produced Sodium [18F]fluoride radiopharmaceutical meets the acceptance criteria defined in the specification, based on Ph. Eur. monograph.
Keywords: Sodium [18F]fluoride, production, in-house method

Item Type:	Conference or Workshop Item (Poster)
Subjects:	Medical and Health Sciences > Basic medicine
Divisions:	Faculty of Medical Science
Depositing User:	Marija Atanasova
Date Deposited:	08 Apr 2024 07:42
Last Modified:	17 Jun 2024 07:12
URI:	https://eprints.ugd.edu.mk/id/eprint/33981

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