Stability assessment of PET radiopharmaceuticals under extreme conditions: an ICH-compliant study on radiochemical and enantiomeric purity
In this report, the stability of the [<sup>18</sup>F]FET and [<sup>11</sup>C]MET radiopharmaceuticals was studied within the expiration time. [<sup>18</sup>F]FET remained stable until the end of the 12-h expiration time. [<sup>11</sup>C]MET samples stored even under stressed conditions did not decrease under the acceptable limit during the shelf life of the radiopharmaceutical. These findings confirm that both radiopharmaceuticals maintain their stability within the defined shelf life, ensuring their reliability for clinical use. Further studies could explore additional environmental stress factors to enhance stability assessments and optimize storage conditions.
Authors
- István Jószai (ORCID: https://orcid.org/0000-0002-1940-3390)
- Ágnes Fekete (ORCID: https://orcid.org/0000-0003-3058-7570)
- Viktória Forgács (ORCID: https://orcid.org/0000-0002-8586-3942)
- Gergely Farkasinszky
- Lívia Vonza
Institutions
- University of Debrecen (HU)
Publication Details
- Journal
- EJNMMI Radiopharmacy and Chemistry
- Published
- 2025-11-12
- DOI
- https://doi.org/10.1186/s41181-025-00399-8
- Primary Topic
- Medical Imaging Techniques and Applications
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Debreceni Egyetem