Tracer library / [18F]Florbetaben

[18F]Florbetaben
Also written as [18F]Florbetaben; [F-18]Florbetaben; Florbetaben
- Radionuclide
- F-18 t½ 109.77 min
- Modality
- PET
- Production route
- —
- Stage
- Approved
- Syntheses indexed
- 1
What it is
Regulatory status
- FDA
- Yes — 2014; Neuraceq (florbetaben F-18); sponsor LANTHEUS; NDA 204677 Drugs@FDA / openFDA drug registry, NDA 204677, original approval 2014-03-19, marketing status 'Prescription' — https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA204677%22 (queried 2026-09-18)
- EMA (centralised)
- Yes — 2014; Neuraceq (florbetaben (18F)); Lantheus Germany GmbH; EMEA/H/C/002553 EMA medicines register (JSON export 2026-09-18), EPAR Neuraceq: status 'Authorised', marketing authorisation date 2014-02-20 — https://www.ema.europa.eu/en/medicines/human/EPAR/neuraceq
- Other approvals
- —
- Brand names
- —
Published syntheses
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| PET-MF-2V-IT-1 vendor not confirmed -- see article | — | HPLC | 20-25% not corrected | >95% | methanesulfonic acid…methanesulfonic acid 2-[2-(2-{4-[2-(4-methylamino-phenyl)-vinyl]-phenoxy}-ethoxy)-ethoxy]-ethyl ester | 23085550 2013 Appl Radiat Isot using the commercial PET-MF-2V-IT-1 synthesizer - 20-25% yield (uncorrected for decay) |
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Get in touchQuality control Preliminary - inferred from compound class
- Ph. Eur. monograph
- not verified No Ph. Eur. check is recorded for this entry.
- USP monograph
- not verified No USP check is recorded for this entry.
How this set was arrived at. base set per Ph. Eur. general monograph 0125 (rule); organic-phase radiosynthesis assumed from isotope/compound class, no synthesis data confirming it -> GC residual solvents (preliminary); conventional nucleophilic 18F-fluorination assumed from isotope/compound class, no synthesis data confirming K222 use -> Kryptofix test (preliminary)
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]Florbetaben.
Get in touchNotes
Added from reverse module search (stage 6); 2 article(s) with F-18.