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Stability Testing

Diteba has a dedicated stability and analysis group providing services for all stages of drug development, from early research and development to commercial and post approval studies. These services are provided in full compliance with International Conference on Harmonisation (ICH), Health Canada and U.S. Food and Drug Administration (FDA) guidelines.

Diteba provides reliable stability storage monitored by a fully validated environmental monitoring system, and backed-up by a gas-powered electrical generator and UPS (Uninterrupted Power Supply) systems to enable continued data acquisition during power interruptions or brownouts.

Stability Storage and Testing

Our Stability department is integrated within the laboratory operations and provides the following services:

  • Protocol design
  • Long term stability
  • Accelerated stability
  • Customized conditions
  • Drug substance stability
  • Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA) stability
  • Commercial, post market stability
  • Comparator stability
  • Formulation evaluation stability
  • Forced degradation studies
  • Photostability (UV and daylight)
  • Freeze-Thaw studies

ICH Stability Storage Conditions

We can accommodate customized storage conditions outside of ICH as well.

  • 25°C /60% RH
  • 30°C /65% RH
  • 40°C /75% RH
  • 5°C, -20°C, -80°C
  • Photostability (UV and Daylight)

Stability Chambers

Our temperature/humidity stability chambers are continuously monitored by a fully validated Environmental Monitoring System. It provides instant data regarding the individual storage condition while ensuring compliance with FDA 21 CFR 11. Our natural gas-powered roof top generator ensures continuous power during power failures for all stability chambers, fridges and freezers.

Compliance with Regulations

Our services are performed in strict compliance with the requirements of:

  • The US Food and Drug Administration (FDA)
  • Health Canada
  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • International Conference on Harmonization (ICH) guidelines