Table 2 Specifications of ISO-1 for clinical studies
From: Automation of the Radiosynthesis of Six Different 18F-labeled radiotracers on the AllinOne
Test | Acceptance criteria |
|---|---|
Filter membrane integrity test | Following manufacturer’s specification |
pH | 4.5–7.5 |
Appearance | Clear, colorless, and particle-free |
Strength (@EOS) | 4–14 mCi/mL |
Radionuclide identity (dose calibrator) | 105.0Â min to 115.0Â min |
Radionuclidic purity (annual test) | ≥99.5 % of phantoms |
Radiochemical purity | ≥90 % |
Radiochemical identity | RT difference of radioactivity and reference peaks ≤ 10 % |
Drug mass | ≤10 μg/ injection dose |
Chemical impurity | ≤10 μg/ injection dose |
Kryptofix | ≤50 μg/mL |
Bacterial Endotoxin | ≤175 EU/ total dose |
Residue solvent: MeCN | ≤0.41 mg/mL (4.1 mg/day max) |
Residue solvent: MeOH | ≤3 mg/mL (30 mg/day max) |
Residue solvent: EtOH | ≤100 mg/mL |
Residue solvent: DMSO | ≤5 mg/mL (50 mg/day max) |
Sterility (results after 14Â days) | Sterile (no visible growth) |