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Quality-based design and stability assessment of sodium 18F-fluoride radiopharmaceutical for PET imaging

Authors

  • Marija Atanasova Lazareva 1. University Institute for Positron-Emission Tomography, Skopje, Republic of North Macedonia 2. Faculty of Medical Sciences, Goce Delcev University, Stip, North Macedonia https://orcid.org/0000-0002-1516-8303
  • Maja Velickovska University Institute for Positron-Emission Tomography, Skopje, Republic of North Macedonia
  • Filip Jolevski University Institute for Positron-Emission Tomography, Skopje, Republic of North Macedonia
  • Katerina Kolevska 1. University Institute for Positron-Emission Tomography, Skopje, Republic of North Macedonia, 2. Faculty of Medical Sciences, Goce Delcev University, Stip, North Macedonia https://orcid.org/0000-0002-8312-218X
  • Maja Chochevska 1. University Institute for Positron-Emission Tomography, Skopje, Republic of North Macedonia, 2. Faculty of Medical Sciences, Goce Delcev University, Stip, North Macedonia https://orcid.org/0000-0002-8720-342X
  • Paulina Apostolova Faculty of Medical Sciences, Goce Delcev University, Stip, North Macedonia https://orcid.org/0000-0002-3059-2006
  • Nevena Manevska 1. University Institute for Positron-Emission Tomography, Skopje, Republic of North Macedonia, 2. Institute of Pathophysiology and Nuclear Medicine, Faculty of Medicine, University of Ss. Cyril and Methodius in Skopje, Skopje, Republic of North Macedonia https://orcid.org/0000-0001-7168-3775
  • Ana Ugrinska Institute of Pathophysiology and Nuclear Medicine, Faculty of Medicine, Ss. Cyril and Methodius Univeristy in Skopje, Skopje, Republic of North Macedonia https://orcid.org/0000-0001-6558-3890
  • Emilija Janevik-Ivanovska Faculty of Medical Sciences, Goce Delcev University, Stip, North Macedonia https://orcid.org/0000-0002-8493-5481

DOI:

https://doi.org/10.20450/mjcce.2025.3234

Keywords:

[18F]Sodium fluoride, radiopharmaceutical, stability, quality control, shelf life

Abstract

This study presents the results of the stability assessment conducted on three production batches of sodium 18F-fluoride radiopharmaceutical intended for intravenous injection. The objective was to evaluate the physicochemical and microbiological stability, establish an appropriate shelf life, and confirm the overall quality of this radiopharmaceutical over a defined period under controlled storage conditions.

The stability study was designed to assess the quality of in-house produced sodium 18F-fluoride radiopharmaceutical, with quality control tests performed at two-hour intervals. All pre-release and post-release tests established in the [18F]NaF specification were examined, including appearance, identification, pH, chemical, radiochemical, radionuclide purity, bacterial endotoxins, and sterility. The results of pH, chemical, radiochemical, and radionuclide purity met the acceptance criteria for all tested points across the three batches, demonstrating the physicochemical stability of the preparation. Microbiological stability was also proved through compliance with bacterial endotoxins and sterility requirements.

Overall, the obtained results confirmed that sodium 18F-fluoride is stable for up to 10 hours after the end of synthesis, ensuring its suitability for clinical use.

 

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Published

2025-12-03

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How to Cite

Atanasova Lazareva, M., Velickovska, M. ., Jolevski, F. ., Kolevska, K. ., Chochevska, M. ., Apostolova, P. ., Manevska, N. ., Ugrinska, A. ., & Janevik-Ivanovska, E. (2025). Quality-based design and stability assessment of sodium 18F-fluoride radiopharmaceutical for PET imaging. Macedonian Journal of Chemistry and Chemical Engineering, 44(2). https://doi.org/10.20450/mjcce.2025.3234

Issue

Vol. 44 No. 2 (2025)

Section

Pharmaceutical Engineering

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Copyright (c) 2025 Marija Atanasova Lazareva, Maja Velickovska, Filip Jolevski, Katerina Kolevska, Maja Chochevska, Paulina Apostolova, Nevena Manevska, Ana Ugrinska, Emilija Janevik-Ivanovska

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