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[18F]-FBB, Florbetaben (18F) injection
[18F]-FBB is a diagnostic radiotracer developed for routine clinical application to visualize β-amyloid plaques in the brain. It is indicated for Positron Emission Tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment. β-amyloid is a key neuropathological hallmark of AD.
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Test |
Technique / instrument |
|
Appearance |
Visual |
|
Radionuclidic Identity |
Gamma-ray spectroscopy with a Multi Channel Analyser (MUCHA) |
|
Radionuclidic Identity |
Half-life determination with a dose calibrator or alternative detector |
|
pH |
pH-meter or pH strips with reading through a reflexion photometer |
|
Chemical purity (FBB and related substances, BOC-Stilbene triethylene glycol and stilbene mesylate) |
Gradient HPLC with UV detector |
|
Impurity kryptofix 222 (aminopolyether) |
Spot test |
|
Residual solvents |
Gas chromatography |
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Bacterial endotoxins (LAL) |
Endosafe Portable Test System (nexgen PTS) |
|
Radiochemical purity |
Radio-HPLC (gradient with UV detector) |
|
Radiochemical purity |
Radio-TLC |
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Radiochemical identity |
Radio-HPLC |
|
Osmolality ("not compulsory") |
Osmometer |
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Radionuclidic purity |
Gamma-ray spectroscopy with a multichannel analyser (MUCHA) |
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Sterility |
Compendial method |
|
Radioactivity, volumic activity |
Dose calibrator |