Table 9 Analytical data of brexpiprazole for solution stability
Test solution | Standard solution | Acceptance criteria | Conclusion | ||||
|---|---|---|---|---|---|---|---|
Time point | Area | % Absolute difference | Time point | Area | % Absolute difference | ||
Initial | 16,238,783 | NA | Initial | 16,245,895 | NA | % Absolute difference NMT 2.0 | Both standard solution and sample solution were found stable for 24 hours |
12 h | 16,217,981 | 0.13 | 12 h | 16,226,483 | 0.12 | ||
24 h | 16,211,870 | 0.17 | 24 h | 16,216,591 | 0.18 | ||