Table 5.
Results of the estimation of quality of the lyophilized venom candidate
| Test items | Specification | Test 1 | Test 2 | Test 3 | Test result |
|---|---|---|---|---|---|
| Identification | Detect precipitation line | Pass | Pass | Pass | Pass |
| Appearance | White or Lemon Yellow powder | Pass | Pass | Pass | Pass |
| Sterility | No observed microorganism | Pass | Pass | Pass | Pass |
| Moisture content (Water determination) | < 3.0% | 1.36% | 1.34% | 1.38% | 1.36% |
| Uniformity (Mass variation test) | < 10% | 6.3% | 5.8% | 6.3% | 6.1% |
| Foreign Insoluble particle matter | No foreign matter in visual (Optical particle counting: Over 10 μg ≤ 6,000 ea./container) | Pass | Pass | Pass | Pass |
| Leakage | Δp < 3.82 | 2.85 | 3.03 | 2.90 | 2.93 |