Tracer library / [18F]NaF
[18F]NaF
Also written as [18F]NaF; [F-18]NaF; F-18 NaF; F-18-NaF; NaF; sodium fluoride
- Radionuclide
- F-18 t½ 109.77 min
- Modality
- PET
- Production route
- —
- Stage
- Approved
- Syntheses indexed
- 10
What it is
- Compound class
- Inorganic radiopharmaceutical (fluoride ion, sodium salt)
- Target / mechanism
- Hydroxyapatite crystal surface of bone mineral — fluoride/hydroxyl ion exchange forming fluorapatite, reflecting osteoblastic activity and bone perfusion PMID 25208282
- Clinical application
- Skeletal PET/CT: detection of osteoblastic bone metastases and other bone pathology PMID 25208282
- Theranostic pair
- —
Regulatory status
- FDA
- multiple ANDA generic approvals, e.g. PETNET Solutions (2015); no single NDA/brand — sodium fluoride F18 is a multi-source generic radiopharmaceutical FDA (Drugs@FDA/openFDA): e.g. ANDA203890 (PETNET), approved 2015-09-28; several other ANDAs (Cardinal Health 414, Precision Nuclear, 3D Imaging Drug, The Feinstein Institute)
- EMA (centralised)
- No EMA medicines register export (2026-09-09): no centrally authorised 'sodium fluoride (18F)' product
- Other approvals
- —
- Brand names
- —
Published syntheses
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| TRACERlab FX FN GE HealthCare | custom manifold | SPE | >95% not corrected | — | Sodium fluoride Sigma-Aldrich | 21769163 2011 J Labelled Comp Radiopharm a Tracerlab FXFN was reconfigured to allow full automation of the method for producing sodium fluoride - Typical yields of [18F]sodium fluoride were >95% (non-decay corrected, n = 10). |
| Clio Comecer | custom manifold | SPE | ≥ 97% decay-corrected | 100% | [18F]fluoride | 39904855 2025 EJNMMI Radiopharm Chem Sodium 18F-fluoride was produced on a semi-automated volumetric dispenser for radiopharmaceuticals Clio (Comecer S.p.A, Castelbolognese, Italy). - The [18F]NaF decay-corrected radiochemical yield was ≥ 97%. |
| CFN-MPS100 Sumitomo | custom manifold | SPE | — | 99.5 | — | 27744544 2017 Ann Nucl Med 18F-NaF was prepared using a CFN multipurpose synthesizer CFN-MPS100 (Sumitomo Heavy Industries). |
| TRACERlab FX FN GE HealthCare | fixed tubing | SPE | >90% not corrected | — | [18O]H2O ABX | 19762249 2010 Appl Radiat Isot using a modified GE Tracerlab FX-FN - Typical yields of [18F]sodium fluoride were >90% (non-decay corrected). |
| Explora Siemens / CTI | — | — | >90% | >98% | — | 35593337 2022 Curr Radiopharm Explora FDG4 module is described - [18F]-NaF was obtained in a high radiochemical yield (>90%, n=100) in 10 min total preparation time. |
| Explora Siemens / CTI | — | — | — | 98.5±1.5% | — | 25097896 2014 Hell J Nucl Med using the Explora FDG4 radiochemistry module (EFRM) by single run of Cyclotron |
| Synthera IBA | — | — | >98% not corrected | — | — | 34826753 2022 Appl Radiat Isot using SYNTHERA module with a modification in integrated fluidic processor (IFP) - more than 98% non-decay corrected radiochemical yield (RCY) within 5 min |
| iMiDEV PMB-Alcen | — | — | 87% decay-corrected | — | sodium [18F]fluoride | 33912890 2021 Lab Chip iMiDEV™ microfluidic system is a new automated tool for a small-scale production of radiopharmaceuticals. - A single-dose of radiotracer was produced in an average radiochemical yield of 87% (decay corrected) within 8 min |
| AllinOne (AiO) Trasis | — | — | ~97% | — | — | 26002274 2015 Appl Radiat Isot AllInOne and miniAllInOne synthesizers - Both modules allow to prepare [(18)F]NaF in good radiochemical yield (around 97%) in less than 4min with the same specifications. |
| miniAllinOne Trasis | — | — | ~97% | — | — | 26002274 2015 Appl Radiat Isot AllInOne and miniAllInOne synthesizers - Both modules allow to prepare [(18)F]NaF in good radiochemical yield (around 97%) in less than 4min with the same specifications. |
Clinical literature
Clinical studies in the indexed corpus, ordered by design (multicentre, prospective, retrospective, others, case reports last) and then by year. Titles and links only, as published; this is not a summary of the evidence.
- The value of baseline 18F-sodium fluoride and 18F-choline PET activity for identifying responders to radium-223 treatment in castration-resistant prostate cancer bone metastases.2024 · Eur Radiol · Prospective
- The Clinical Utility of 18F-Fluciclovine PET/CT in Biochemically Recurrent Prostate Cancer: an Academic Center Experience Post FDA Approval.2021 · Mol Imaging Biol · Retrospective
Precursor
- Common precursor
- —
- Suppliers seen in the literature
- —
- Cited suppliers in indexed syntheses
- ABX, Sigma-Aldrich
- Typical final purification
- —
Need this precursor?We can point you to suppliers for [18F]NaF, or handle the enquiry for you.
Get in touchQuality control Pharmacopoeial monograph
- Ph. Eur. monograph
- 2100 Sodium fluoride (18F) injection
- USP monograph
- Sodium Fluoride F 18 Injection long-standing USP-NF radiopharmaceutical monograph
How this set was arrived at. Cross-checked against Ph. Eur. general monograph 0125 (base set), EANM validation guideline (PMC7016057) and cGRPP guidance (PMC7881071). Draft X-marks consistent with the base set; tracer-specific analytical tests follow the specific monograph where one exists.
Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived
Setting up quality control?We can help you scope the equipment needed to release [18F]NaF.
Get in touchNotes
Added from reverse module search (stage 6); 13 article(s) with F-18. Stage set to 'Approved' at stage 23 -- Approval FDA field on this row (multiple ANDA generic approvals, e.g. PETNET Solutions (2015); no single NDA/bra).