Analysis | Method | Specifications EOS | Results (n = 14) |
---|---|---|---|
Appearance | Visual | Clear, no color | Pass |
pH | pH strip | 4.0–8.0* | 5.4 ± 0.2 |
Peptide DOTATATE | Calculation | ≤60 μg* | 57.3 ± 0.5 μg |
Radiochemical identity | Ultra-performance liquid chromatography retention time | ±10% | 0.90% ± 0.05% |
Radiochemical purity | (100-A) × T = % | ≥91% | 98.4% ± 0.9% |
Radionuclidic purity | γ-511 and 1,077 keV | ≥98% | 99.7% ± 0.3% |
Radionuclide identification | Half-life | 62–74 min* | 67.5 ± 0.5 min |
Pyrogenicity | Inoculation | ≤8.3 IU/mL* | Pass |
Filter integrity | Bubble point | ≥345 kPa (50 psi) | Pass |
Zinc/iron | Strips | ≤10 μg/GBq | <1 μg/GBq |
67Ga and 66Ga contents | γ-ray analysis | ≤2% | 67Ga ≤ 0.052% ± 0.004%† 66Ga ≤ 0.017% ± 0.006%† |
↵* Our release criteria.
↵† Values recalculated to moment of EOS from results obtained 16–24 h after EOS.
A = percentage of radioactivity due to 68Ga impurity (retardation factor = 0–0.1) determined by instant TLC; T = proportion of the radioactivity in the area of the peak due to 68Ga-DOTATATE relative to the total areas of the peaks in the chromatogram obtained from ultra-high-performance liquid chromatography analysis.