ICH Stability Testing

Stability testing and a well-designed ICH-compliant stability program are critical elements of a rigorous drug formulation and development plan. Our facility is equipped with state-of-the-art temperature and humidity controlled and monitored chambers for accelerated and long-term stability testing. Particle Sciences' pharmaceutical stability programs operate under ICH guidelines, supplemented by custom programs that are designed as needed. Our comprehensive physical characterization and analytic capabilities complement our stability testing, providing our clients with a single source for a complete stability solution. Of course, our facilities have backup gas-powered generators to ensure that your samples remain under protocol directed test conditions even in the event of a widespread power failure.

Services include:

  • Stability storage
  • Photostability (ICH Q1B)
  • Sample management during a study
  • Stability protocol development
  • Stability table preparation and maintenance
  • In-house stability testing
  • Stability conditions include
    • 25°C/60% RH
    • 30°C/60% RH
    • 30°C/65% RH
    • 40°C/75% RH
    • 5°C
    • -70°C