18F-FBB

[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.

The principal tests for[18F]-FBB are:

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

Bacterial endotoxins (LAL)

Endosafe Portable Test System (nexgen PTS)

Radiochemical purity

Radio-HPLC (gradient with UV detector)

Radiochemical purity

Radio-TLC

Radiochemical identity

Radio-HPLC

Osmolality ("not compulsory")

Osmometer

Radionuclidic purity

Gamma-ray spectroscopy with a multichannel analyser (MUCHA)

Sterility

Compendial method

Radioactivity, volumic activity

Dose calibrator