+Parameter | Specification | [68Ga]Ga-DOTA-CP04 |
---|---|---|
Appearance | Clear and colorless | Pass |
pH | 4–8 | 5–6 |
Radionuclidic identity (half-life) | 62–74 min | Pass |
Radiochemical identity (HPLC) | Reference standard ±1.0 min | Pass |
Radiochemical Purity (HPLC) | ≥ 90% [68Ga]Ga-DOTA-CP04 < 8% oxidized material | 92–94% 4–6% |
Radiochemical Purity (TLC) | ≥ 98% ≤ 2% free Ga-68 | > 98% < 2% |
Ethanol content | ≤10% | 9–10% |
Bubbling point test | ≥ 55 psi | Pass |
Sterility | Sterile | No growth |
Endotoxin | < 175 IU per dose | < 5 IU per dose |