Table 3.
Test items | Specification | Test 1 | Test 2 | Test 3 |
---|---|---|---|---|
Identification | Detect precipitation line | Pass | Pass | Pass |
Appearance | White or lemon yellow powder | Pass | Pass | Pass |
Sterility | No observed microorganism | Pass | Pass | Pass |
Moisture content (water determination) | < 3.0% | 1.34% | 1.38% | 1.38% |
Uniformity (mass variation test) | < 10% | 6.1% | 6.0% | 6.4% |
Foreign insoluble particle matter | No foreign matter in visual (optical particle counting: over 10 μm ≤ 6000 ea./container) | Pass | Pass | Pass |
Leakage | ∆P < 3.82 | 2.86 | 2.93 | 2.91 |