Stability Studies
  • Register

Stability studies are performed for active pharmaceuticals and finished dosage forms. Assistance can be provided with the design of stability protocols and methods. PharmAssist can store the samples on site and maintain the calendar pull dates. Additional chambers for accelerated and real-time conditions are added to meet customer demands. For clients who generate their own stability samples, we offer analyses using the provided methods. Turnaround time is set by the customer, typically 1-2 weeks. We realize that there is rarely a "routine" analysis involved in stability work; our scientific depth and corporate philosophy enable us to detect potential problems and to provide effective solutions in a timely manner.

  • Protocol Development
  • Long Term Stability Testing
  • Accelerated Stability Testing
  • Degradation or Stress Studies
  • Comparator Stability Testing
  • Statistical Analysis and Data Evaluation

Each chamber operates independently with its own temperature and humidity controls. All storage chambers are continuously monitored by a computerized Rees monitoring system. All chambers are on generator backup.

ICH Storage Conditions include:

  • 25°C / 60% RH
  • 30°C / 65% RH
  • 40°C / 75% RH
  • 2°C - 8°C
  • - 20°C
  • ICH photostability, Option I
  • Other conditions available, please contact us with your specific need

Questions

Powered by ChronoForms - ChronoEngine.com

  • fr-FR
  • English (UK)