Tracers / [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
12

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

Clinical use

Typical injected activity
Uptake time

Reported in the literature. Not a dosing recommendation.

Published syntheses

ModuleCassettePurificationYield %RCP %Precursor / supplierSource
TRACERlab FX FN
GE HealthCare
custom manifoldSPE>95%
no
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 manifoldSPE≥ 97%
yes
100%[18F]fluoride39904855
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 manifoldSPE99.527744544
2017 Ann Nucl Med
18F-NaF was prepared using a CFN multipurpose synthesizer CFN-MPS100 (Sumitomo Heavy Industries).
TRACERlab FX FN
GE HealthCare
fixed tubingSPE>90%
no
[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).
38787606
2024 FASEB J
>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.
98.5±1.5%25097896
2014 Hell J Nucl Med
using the Explora FDG4 radiochemistry module (EFRM) by single run of Cyclotron
fluoride ion from the cyclotron21524826
2011 Rev Esp Med Nucl
establish an automated procedure for the preparation of sodium fluoride (18)F injection using the resources available in our laboratory for the preparation of (18)FDG
more than 98%
no
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
87%
yes
sodium [18F]fluoride33912890
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
around 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.
around 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.

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Quality control Pharmacopoeial monograph

Ph. Eur. monograph
2100
USP monograph
USP monograph: Sodium Fluoride F 18 Injection (long-standing USP-NF radiopharmaceutical monograph)
AppearancepHRCP HPLCRCP TLCRadionuclidic (HPGe)Half-lifeActivityEndotoxins (LAL)SterilityFilter integrity
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

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Notes

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).