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Stability Testing

At Aurigene Pharmaceutical Services we have a vast experience in generating stability testing data for drug substance (DS) and drug products (DP) in accordance with ICH guidelines or as per requirements of our clients. Our state-of-the-art facility is US FDA audited and all our labs are equipped with electronic lab note book. An audit trail ensures that data is traceable at any time and stability protocols and reports are electronically signed.

 

Our Stability Testing Services include:

  • Full range of stability storage conditions for the four climatic zones
  • Stability studies under accelerated / stress conditions using standard ICH conditions
  • Stability studies under controlled conditions from -20°C to +40°C and a range of humidity conditions from 60% RH to 75% RH
  • ICH photo stability
  • Expertise in designing stability studies for APIs, intermediates and formulations

Features of our Stability Chambers

  • Concurrent documentation of loading and withdrawal of stability samples in to/from stability chambers.
  • Stability chambers are maintained, monitored and alarmed through computerized systems. Stability chambers have four in built sensors in different locations for temperature and humidity mapping.
  • All the stability chambers have a 24/7 emergency backup for continues power supply.