Table 2 Product specifications for [68Ga]Ga-ABY-025
From: Optimized, automated and cGMP-compliant synthesis of the HER2 targeting [68Ga]Ga-ABY-025 tracer
Test attributes | Product Specification |
|---|---|
Radioactivity concentration | ≥ 30 MBq/mL |
Appearance | Clear and/or slightly yellow. Free of visible particles |
pH | 4.0–8.0 |
Product identity [68Ga]Ga-ABY-025 | |RtRD − RtUV| ≤ 60 s |
Concentration of ABY-025 (principal peak on UV) | 40–60 µg/mL |
Radiochemical impurity [68Ga]-ions and/or unidentified radioactive impurities = B | ≤ 3% |
Total radiochemical purity[68Ga]Ga-ABY-025 RCPTot = (100–B) × T | ≥ 91% |
Chemical impurity (peaks except principal peak on UV) | ≤ 10 µg/mL |
Filter integrity | ≥ 3.5 bar |
Bacterial endotoxins | < 17.5 IU/mL |
Ethanol content | < 80 mg/mL |
Sterility | Sterile, 0 CFU |
Radionuclidic identity, half-life 68Ga | 62–74 min |
Radiochemical stability 2 h EOS | RCPTot ≥ 91% |