BLIND COMPARATOR &
STABILITY STUDIES

BLIND COMPARATOR &
STABILITY STUDIES

Blind Comparator Stability Studies

Boston Analytical tests new drugs against existing medications in the same therapeutic class in blind comparator stability studies. We test your innovator drug, over time and at different temperatures, to verify its potency and stability. The commercial product, in its original packaging, is used as a control.

To assess the performance of the blinded product, Boston Analytical applies existing methods or develops and validates new analytical methods for testing. Testing needs vary, but typically, Boston Analytical performs dissolution, appearance, identification, impurities, and assay tests. For example, we test the release rate of the active pharmaceutical ingredient (API) in media of different pHs, such as those that simulate gastric fluids.

Blind Comparator Stability Studies Services

  • Formulation changes, over-encapsulation, or de-inking
  • Dissolution Testing
  • Appearance
  • Identification
  • Assay
  • Moisture Monitoring
  • Purity Testing
  • Degradation Products
  • ICH Stability Conditions
  • Demonstrate equivalence or superiority to a marketed product
  • Show equivalent stability profile
  • Derive data supporting bioavailability
  • GMP Stability and Product Characterization
GMP stability and product characterization