Table 4 Radiochemical purity assessed using iTLC method during 4 h
RCP using iTLC method | ||||
|---|---|---|---|---|
Batch 1 | Batch 2 | Batch 3 | ||
Final vial radioactivity | 586 MBq | 661 MBq | 594 MBq | |
T = 0 h | RCP | 99.00% | 99.30% | 99.40% |
98.80% | 99.10% | 99.20% | ||
98.60% | 99.10% | 99.30% | ||
Colloidal forms | 0.57% | 0.53% | 0.39% | |
0.66% | 0.65% | 0.46% | ||
1.07% | 0.49% | 0.62% | ||
Free Ga3+ | 0.39% | 0.14% | 0.21% | |
0.53% | 0.26% | 0.30% | ||
0.34% | 0.45% | 0.10% | ||
T = 1 h | RCP | 99.40% | 99.50% | 99.60% |
99.10% | 99.50% | 99.40% | ||
98.90% | 99.50% | 99.50% | ||
Colloidal forms | 0.57% | 0.12% | 0.23% | |
0.67% | 0.13% | 0.58% | ||
0.84% | 0.12% | 0.33% | ||
Free Ga3+ | 0.03% | 0.37% | 0.20% | |
0.28% | 0.36% | 0.02% | ||
0.24% | 0.39% | 0.15% | ||
T = 2 h | RCP | 99.60% | 99.60% | 99.70% |
99.00% | 99.30% | 99.60% | ||
99.30% | 99.50% | 99.90% | ||
Colloidal forms | 0.08% | 0.06% | 0.20% | |
0.57% | 0.36% | 0.25% | ||
0.64% | 0.16% | 0.06% | ||
Free Ga3+ | 0.35% | 0.35% | 0.14% | |
0.40% | 0.32% | 0.14% | ||
0.08% | 0.38% | 0.05% | ||
T = 3 h | RCP | 99.10% | 99.40% | 99.70% |
99.70% | 99.50% | 99.40% | ||
99.50% | 99.30% | 99.70% | ||
Colloidal forms | 0.84% | 0.41% | 0.29% | |
0.25% | 0.46% | 0.41% | ||
0.05% | 0.55% | 0.26% | ||
Free Ga3+ | 0.07% | 0.19% | 0.02% | |
0.08% | 0.05% | 0.23% | ||
0.41% | 0.14% | 0.03% | ||
T = 4 h | RCP | 100% | 98.50% | 99.50% |
99.70% | 99.40% | 99.40% | ||
99.60% | 99.50% | 99.50% | ||
Colloidal forms | 0.02% | 1.27% | 0.21% | |
0.28% | 0.52% | 0.54% | ||
0.40% | 0.01% | 0.15% | ||
Free Ga3+ | 0.03% | 0.20% | 0.26% | |
0.10% | 0.04% | 0.09% | ||
0.02% | 0.49% | 0.40% | ||