18F-FDG

18F-FDG (Fluodeoxyglucose-18F injection)

18F-FDG PET has become a common imaging modality in oncology. 18F-FDG is an analogue of glucose that contains the radionuclide Fluorine-18.  This radiotracer provides valuable functional information based on the increased glucose uptake and glycolysis of cancer cells.

Fluorine F-18 decays by positron (β+) emission and has a physical half-life of 109.7 minutes.

The quality requirements of 18F–FDG are set out in various pharmacopoeia including the USP, BP, EP…

Although there are some differences among these references, the philosophy and key analysis are similar and require the same analytical equipment.

The principal tests for 18F-FDG are:

Test

Technic/instrument

Appearance

Visual

Radionuclidic Identity

Gamma-ray spectroscopy with a multichannel analyser

Radionuclidic Identity

Half-life determination with a dose calibrator

pH

pH-meter or pH strips with reading through a reflexion photometer

Chemical purity (Chloro-DG, FDG)

HPLC with a carbohydrate detector

Impurtiy kryptofix (aminopolyether)     

Spot test

Residual solvents

Gas chromatography

Bacterial endotoxins (LAL)

Endosafe Portable Test System (PTS)

Radiochemical purity

Radio-HPLC

Radiochemical purity

Radio-TLC

Radiochemical identity

Radio-HPLC

Osmolality

Osmometer

Radionuclidic purity

Gamma-ray spectroscopy with a multichannel analyser

Sterility

Compendial method

Radioactivity

Dose calibrator