18F-PSMA-1007

[18F]-PSMA-1007  (Fluoro-PSMA-1007 (18F) injection)

[18F]PSMA-1007, positron emission tomography (PET) tracer, specifically targets prostate-specific membrane antigen (PSMA), which is highly expressed in prostate cancer. PSMA-PET is effective especially for regional detection of biochemical recurrence and for recurrent disease with low PSA levels, Cardinale.J. Pharmaceuticals 2017, 10(4), 77. 

The principal tests for [18F]-PSMA-1007 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 (F-PSMA-1007 and related substances)

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 18F-fluoride, 6-[18F]-PSMA-1007

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