Tracer library / [18F]AV-45
Structure of florbetapir (unlabelled parent compound, from PubChem)
Unlabelled parent compoundPubChem CID 57396865

[18F]AV-45

Also written as [18F]AV-45; [18F]florbetapir; [F-18]AV-45; [F-18]florbetapir; AV-45; F-18 AV-45; F-18 Florbetapir
Radionuclide
F-18 t½ 109.77 min
Modality
PET
Production route
—
Stage
Approved
Syntheses indexed
6

What it is

Compound class
Radiolabelled stilbene derivative (amyloid-binding small molecule)
Target / mechanism
β-amyloid neuritic plaques (Kd approx. 3.7 nM in postmortem brain homogenates) PMID 23527322
Clinical application
PET imaging of the brain to estimate β-amyloid neuritic plaque density in adults with cognitive impairment, for evaluation of Alzheimer's disease and other causes of cognitive decline FDA label NDA202008
Theranostic pair
—

Regulatory status

FDA
2012, Amyvid, Avid Radiopharmaceuticals (Eli Lilly) FDA (Drugs@FDA/openFDA): NDA202008, approved 2012-04-06
EMA (centralised)
2013, Amyvid, Eli Lilly EMA medicines register export (2026-09-09): EMEA/H/C/002422, 'Authorised', authorised 14 Jan 2013
Other approvals
—
Brand names
Amyvid

Clinical use

Typical injected activity
370 MBq (10 mCi) as a single IV bolus FDA label NDA202008 (human clinical dosing)
Uptake time
10-minute PET scan performed within 90 minutes after administration FDA label NDA202008

Reported in the literature. Not a dosing recommendation.

Published syntheses

ModuleCassettePurificationYield %RCP %Precursor / supplierSource
TRACERlab FX FN
GE HealthCare
fixed tubingHPLC14.8 ± 2.1%
not corrected
>95%AV-45 precursor (O-tosylated precursor)
Wuxi Jiangyuan Industrial Technology and Trade Corporation
35494660
2022 Front Chem
Radiochemical synthesis and purification of [18F] AV-45 was carried out using a Tracerlab FXF-N Synthesizer - the average non-decay corrected radiochemical yield of [18F]AV-45 was 14.8 ± 2.1% (n = 4)
BNU F-A2custom manifoldSPE33.6 ± 5.2%
(no decay corrected); 50.1 ± 7.9% (decay corrected)
decay-corrected
> 95%1 (-OTs derivative)21055622
2010 Nucl Med Biol
a radiosynthesis module (BNU F-A2) - the automated synthesis yield was 33.6 ± 5.2% (no decay corrected, n = 4), 50.1 ± 7.9% (decay corrected) in 50 min at a quantity level of 10~100 mCi (370~3700 MBq)
——SPE42.7 ± 5.9%
decay-corrected
>95%O-tosylated precursor31697847
2020 J Labelled Comp Radiopharm
TRACERlab FX FN
GE HealthCare
—SPE14.2%>95%—37526186
2024 Curr Med Chem
produced in a simple, stable, and repeatable manner on the Tracerlab FXF-N platform - the radiochemical yield was 14.2 % ± 2.7% (n = 6)
AllinOne (AiO)
Trasis
——31.0%±2.8%
not corrected
>98AV-10538149774
2023 Hell J Nucl Med
can be easily and quickly prepared by the All in One radiochemical synthesis module - the uncorrected synthesis efficiency was about 31.0%±2.8%
Sumitomo synthesizer
Sumitomo
——25.4±7.7%95.3±2.2%tosylate precursor20638295
2010 Appl Radiat Isot
using a tosylate precursor with Sumitomo modules for radiosynthesis under GMP-compliant conditions - The overall yield was 25.4+/-7.7%

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.

  1. [Safety and Effectiveness of NEPTIS Plug-01 and Florbetapir (18F) in Daily Clinical Setting: Based on the Post-Marketing Surveillance Study].
    2019 · Kaku Igaku · Clinical study
  2. CSF biomarkers of Alzheimer's disease concord with amyloid-β PET and predict clinical progression: A study of fully automated immunoassays in BioFINDER and ADNI cohorts.
    2018 · Alzheimers Dement · Clinical study

Precursor

Common precursor
—
Suppliers seen in the literature
—
Cited suppliers in indexed syntheses
Wuxi Jiangyuan Industrial Technology and Trade Corporation
Typical final purification
—

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Quality 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.
AppearancepHRCP HPLCRCP TLCHPLC UVRadionuclidic (HPGe)Half-lifeActivityEndotoxins (LAL)SterilityFilter integrity
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

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Notes

Added from reverse module search (stage 6); 9 article(s) with F-18.
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