Stability Storage & Testing

We have a dedicated stability and analysis group providing services for all stages of drug development, from early research and development to commercial or 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. 

Stability storage

Our Stability department is integrated within the laboratory testing complex 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 and temperature cycling)

ICH stability storage conditions:

  • 25°C/60% RH
  • 30°C/65% RH
  • 40°C/75% RH
  • 5°C, -20°C, -80°C
  • Customized conditions
  • Photostability (UV and daylight)
  • Facility includes available space for expansion to meet any stability storage requirements

Stability chambers:

Our temperature/humidity stability chambers are continuously monitored by the fully validated Rees Scientific CENTRON Monitoring System®. Our natural gas powered roof top generator ensures continuous power during power failures for all stability chambers, fridges and freezers.

“We had a very positive experience working with DiTEBA on our Phase 2 oligonucleotide based drug product. The GMP work conducted with DiTEBA was used to support orphan drug, US and European pre-clinical toxicology, pharmacology, Phase 1 and Phase 2 clinical work as part of an FDA authorized IND and EMA authorized CTAs. That work included analytical methods development, validation, accelerated and long term stability which is still ongoing. We would definitely choose to work with DiTEBA again on future projects.”

- Dayton T. Reardan, Ph.D., RAC - Vice President of Regulatory Affairs