Percentage of failing samples per type of quality analysis in the prevalence studies
| Quality component | FF % (n/N) |
| API content | 16.5 (1701/10 307) |
| Dissolution | 9.1 (296/3261) |
| API ID and semi-quantitation | 7.5 (210/2783) |
| Impurity/Contaminant/Related substance | 3.5 (12/346) |
| Packaging/Label/Physical appearance inspection | 2.8 (129/4612) |
| Other chemical tests* | 4.4 (187/4212) |
| Other physical tests†| 2.2 (71/3290) |
One sample may have been tested for more than one quality test.
*API identification, degradation products, pH and other undeclared chemical tests.
†Includes disintegration, friability, hardness, thickness, wetting time and water absorption testing.
API, active pharmaceutical ingredient; FF, failure frequency.