Table 17 Dissolution of the homemade and reference preparations determined by the USP II paddle method. The test was conducted for two h in pH 6.8 media.
Medium | Time (min) | 21082305-2 (%) | 21091801-2 (%) | 20220927-1 (%) | L20084A (%) |
|---|---|---|---|---|---|
0.1 N HCl | 120 | 0 | 0 | 0 | 0 |
pH 6.8 | 5 | 0.1 | 0.2 | 0.5 | 0.2 |
10 | 0.6 | 0.7 | 0.3 | 0.5 | |
15 | 0.1 | 0.7 | 0.6 | 0.1 | |
30 | 19.4 | 21.2 | 20.8 | 20.4 | |
45 | 54.5 | 57.8 | 57.7 | 55.5 | |
60 | 80.1 | 86 | 86.7 | 81.8 | |
90 | 100.8 | 100.7 | 100.4 | 99.6 | |
120 | 104.2 | 103.3 | 101.9 | 101.7 |
