Table 5 Radiochemical purity assessed using HPLC method during 4 h
RCP using HPLC method | ||||
|---|---|---|---|---|
Batch 1 | Batch 2 | Batch 3 | ||
Final vial radioactivity | 586 MBq | 661 MBq | 594 MBq | |
T = 0 h | RCP | 99.70% | 99.80% | 100% |
99.80% | 99.80% | 100% | ||
99.80% | 99.70% | 99.90% | ||
Free Ga3+ | 0.32% | 0.23% | 0.05% | |
0.18% | 0.16% | 0.05% | ||
0.16% | 0.32% | 0.11% | ||
T = 1 h | RCP | 99.90% | 99.80% | 99.90% |
99.80% | 99.80% | 99.90% | ||
100% | 99.80% | 99.80% | ||
Free Ga3+ | 0.15% | 0.20% | 0.06% | |
0.18% | 0.19% | 0.13% | ||
0.03% | 0.22% | 0.16% | ||
T = 2 h | RCP | 99.90% | 99.90% | 99.80% |
100% | 99.90% | 99.80% | ||
100% | 99.90% | 99.90% | ||
Free Ga3+ | 0.09% | 0.09% | 0.17% | |
0.05% | 0.15% | 0.20% | ||
0.03% | 0.12% | 0.13% | ||
T = 3 h | RCP | 99.90% | 99.80% | 99.80% |
99.90% | 99.70% | 99.90% | ||
99.90% | 99.80% | 99.80% | ||
Free Ga3+ | 0.10% | 0.24% | 0.17% | |
0.15% | 0.30% | 0.12% | ||
0.14% | 0.19% | 0.23% | ||
T = 4 h | RCP | 100% | 99.90% | 99.90% |
100% | 99.70% | 99.90% | ||
100% | 99.90% | 99.70% | ||
Free Ga3+ | 0.02% | 0.13% | 0.10% | |
0.05% | 0.27% | 0.15% | ||
0.02% | 0.06% | 0.30% | ||