Stability Testing & Storage

ECI Pharmaceuticals offers state-of-the-art cGMP stability storage and testing capabilities. Standard storage conditions meet ICH guidelines, and additional storage options offer a range of environmental conditions suitable for specialty products. Each cGMP environmental chamber operates independently with separate temperature and, where applicable, humidity controls. All three chambers are continuously monitored and are supported by full generator back up in case of power failure, with a second backup generator available if needed.

ECI Pharmaceuticals performs release and stability testing for all types of drug products. Appropriate sampling strategies are determined, documented and executed with the utmost care. Analytical services supporting stability programs include:
long-term stability testing, accelerated stability testing, comparative stability testing, forced degradation studies and stability testing of Active Pharmaceutical Ingredient (API) and Clinical Trial Material (CTM). These services support clinical trials, IND, NDA and ANDA applications.

Stability Storage Conditions:
  • 25°C/Ambient
  • 25°C/60%RH
  • 30°C/65%RH
  • 40°C/75%RH