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[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.
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Test |
Technique / instrument |
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Appearance |
Visual |
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Radionuclidic Identity |
Gamma-ray spectroscopy with a Multi Channel Analyser (MUCHA) |
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Radionuclidic Identity |
Half-life determination with a dose calibrator or alternative detector |
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pH |
pH-meter or pH strips with reading through a reflexion photometer |
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Chemical purity (F-PSMA-1007 and related substances) |
Gradient HPLC with UV detector |
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Impurity kryptofix 222 (aminopolyether) |
Spot test |
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Residual solvents |
Gas chromatography |
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Bacterial endotoxins (LAL) |
Endosafe Portable Test System (nexgen PTS) |
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Radiochemical purity |
Radio-HPLC (gradient with UV detector) |
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Radiochemical purity 18F-fluoride, 6-[18F]-PSMA-1007 |
Radio-TLC |
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Radiochemical identity |
Radio-HPLC |
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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 |
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Radioactivity, volumic activity |
Dose calibrator |