Item | Time (hours) | Batch 1 | Batch 2 | Batch 3 | |||
---|---|---|---|---|---|---|---|
Syringe | Vial | Syringe | Vial | Syringe | Vial | ||
Yield (Corrected for decay) | T = 0 | 75.05% | 77.94% | 74.82% | |||
Visual inspection(Criteria: colorless without visible particles) | T = 0 | Colorless No particles | Colorless No particles | Colorless No particles | |||
T = 4 | Colorless No particles | Colorless No particles | Colorless No particles | Colorless No particles | Colorless No particles | Colorless No particles | |
T = 6 | Colorless No particles | Colorless No particles | Colorless No particles | Colorless No particles | Colorless No particles | Colorless No particles | |
T = 24 | Colorless No particles | Colorless No particles | |||||
pH (Criteria: pH 4,0-8,0) | T = 0 | 7.5 | 7.5 | 7.5 | |||
T = 4 | 7.5 | 7.5 | 7.5 | 7.5 | 7.5 | 7.5 | |
T = 6 | 7.5 | 7.5 | 7.5 | 7.5 | 7.5 | 7.5 | |
T = 24 | 7.5 | 7.5 | |||||
Sterility (Criteria: TSB clear after 7-day incubation) | T = 0 | TSB clear | TSB clear | TSB clear | |||
Endotoxin (Criteria: < 50 IU / 2 mL) | T = 0 | < 50 IU/2 ml | < 50 IU/2 ml | < 50 IU/2 ml | |||
Radionuclide purity (Main peak at 141 keV) | T = 0 | Main peak at 141 keV | Main peak at 141 keV | Main peak at 141 keV | |||
Tc-99m colloids (Criteria: ≤10%) | T = 0 | 1,46% | 1,92% | 2,82% | |||
T = 4 | 6,56% | 7,02% | 6,83% | 7,39% | 7,81% | 6,64% | |
T = 6 | 6,65% | 7,18% | 7,60% | 6,47% | 8,51% | 8,40% | |
T = 24 | 10,96% * | 9,44% | |||||
Tc-99m ions (Criteria: ≤2%) | T = 0 | 0,34% | 0,48% | 0,84% | |||
T = 4 | 0,68% | 1,06% | 0,28% | 0,78% | 1,22% | 0,90% | |
T = 6 | 0,58% | 1,02% | 0,82% | 1,10% | 1,10% | 1,56% | |
T = 24 | 1,46% | 1,34% | |||||
Radiochemical purity (Criteria: ≥90%) | T = 0 | 98,20% | 97,60% | 96,34% | |||
T = 4 | 92,76% | 91,92% | 92,89% | 91,83% | 90,97% | 92,46% | |
T = 6 | 92,77% | 91,80% | 91,58% | 92,43% | 90,39% | 90,04% | |
T = 24 | 87.58% * | 89,22% * | |||||
HEPES (Criteria: < 200 μg/patient dosage) | T = 0 | < 200 μg/patient dose | < 200 μg/patient dose | < 200 μg/patient dose |