Yellow Covered Document standard | No of papers excluded |
---|---|
Testing under relevant storage conditions (37°C for elastomeric devices) | 111 |
95–105% of API | 111 |
All samples tested in duplication | 75 |
Low and high ‘clinically significant’ concentrations | 72 |
Complete physical stability testing | 63 |
3 samples at each time point | 51 |
At least 4 time points plus time 0 | 42 |
Use of a stability indicating assay | 13 |
Total | 121 |