Stability Storage and Testing

Stability Testing Services

• Drug substances and intermediates
• IND, NDA, ANDA Registration batches
• Currently doubling capacity
• Commercial products, CTM products
• Forced degradation studies
• Photo stability (UV and Daylight) as per ICH Q1B 
• Temperature cycling (freeze/thaw)
• Protocol design and report writing

Stability Storage Services 

• Long-term and accelerated storage conditions as per ICH Guidelines:
  • 25°C/60% RH
  • 30°C/65% RH
  • 40°C/75% RH
  • 5°C
  • -20°C
• Stability chambers on automated generator back-up