Table 1

Percentage of failing samples per type of quality analysis in the prevalence studies

Quality componentFF % (n/N)
API content16.5 (1701/10 307)
Dissolution9.1 (296/3261)
API ID and semi-quantitation7.5 (210/2783)
Impurity/Contaminant/Related substance3.5 (12/346)
Packaging/Label/Physical appearance inspection2.8 (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.