Table 12 Method precision (dissolution instrument B).
Medium | Time Point (h) | Dissolution (%, lot 20220228-1) | Average (%) | RSD (%) | |||||
|---|---|---|---|---|---|---|---|---|---|
pH 1.2 | 2 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | - |
pH 4.5 | 3 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | - |
pH 5.5 | 4 | 0.1 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 | - |
pH 6.0 | 5 | 0.1 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 | - |
pH 6.8 | 5.08 | 0.2 | 0.3 | 0.3 | 0.2 | 0.2 | 0.2 | 0.2 | - |
pH 6.8 | 5.16 | 0.2 | 0.3 | 0.3 | 0.2 | 0.3 | 0.2 | 0.3 | - |
pH 6.8 | 5.25 | 0.5 | 0.3 | 0.4 | 0.4 | 0.5 | 0.4 | 0.4 | 18.1 |
pH 6.8 | 5.5 | 68 | 71 | 70 | 71 | 70 | 71 | 70.2 | 1.7 |
pH 6.8 | 5.75 | 97.1 | 96.8 | 97.0 | 96.6 | 95.9 | 97.9 | 96.9 | 0.7 |
pH 6.8 | 6 | 97.4 | 97.6 | 97.9 | 98.9 | 98.5 | 98.8 | 98.2 | 0.6 |
pH 6.8 | 6.5 | 98.5 | 99.8 | 99.9 | 100.1 | 99.5 | 99.7 | 99.6 | 0.6 |
