대한방사성의약품학회지 (Journal of Radiopharmaceuticals and Molecular Probes)

  • 제10권1호
  • /
  • Pages.21-26
  • /
  • 2024
  • /
  • 2384-1583(pISSN)
  • /
  • 2508-3848(eISSN)
대한방사성의약품학회 (Korean Society of Radiopharmaceuticals and Molecular Probes)
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Assessment of Radioactivity Yield and Quality Controls of [18F]FDG Production in Mongolia's First Cyclotron Facility: A Two-Year Experience (2022-2023)

  • 투고 : 2024.06.12
  • 심사 : 2024.06.21
  • 발행 : 2024.06.30
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초록

Purpose: The objective of this study was to evaluate the estimated radiochemical yield (RCY) and quality of routine [18F]FDG production over two years (2022 and 2023) at Mongolia's first cyclotron facility, utilizing the MINItrace Qilin cyclotron (GE Healthcare, 9.6 MeV) and FASTLab 2 radiosynthesizer (GE Healthcare). Methods: [18F]Fluoride was generated using a MINItrace Qilin cyclotron, producing up to 2 Ci of radioactivity per run, 2-3 runs per week. The [18F]FDG production was carried out using the FASTLab 2 radiosynthesizer utilizing FDG Duo and Single Citrate cassettes through nucleophilic radiofluorination of mannose triflate followed by basic hydrolysis. Quality Controls, including radiochemical purity, radionuclidic purity and identity, chemical purity, residual solvents, assay for radioactivity, bacterial endotoxins, and sterility, were performed in accordance with United States Pharmacopeia (USP) standards using bSCAN TLC Scanner, Captus-3000 MCA, Scion-456 GC, and Endosafe nexgen-PTS. Facility design and operation were managed in accordance with International Atomic Energy Agency guidelines to ensure GMP compliance. Results: All quality control tests met the USP requirements, ensuring safe injections for patients. The RCY were within acceptable ranges. The RCY of the FASTLab 2 Duo cassette was consistently higher than that of the Single Citrate cassette throughout the study period. The RCY for both cassettes were gradually decreased over time, with no significant correlation between cyclotron maintenance and subsequent RCY. Conclusions: Further investigation is needed to identify factors contributing to the decreasing radiochemical yield.

키워드

과제정보

This work was supported by a grant from the Korea Institute of Radiological and Medical Sciences (KIRAMS), funded by MSIT, Republic of Korea (No. 50432-2024).

참고문헌

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