Table 2.

Specifications of ISO-1 for clinical studies

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)	105.0 min to 115.0 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 14 days)	Sterile (no visible growth)