Stability Testing

Standard and customized services - placebos to controlled drugs  

As a leader in integrated services from molecule to market, we offer stability services for preclinical and clinical studies, drug registration, and commercial products. From placebos to controlled drugs, our scientists have years of experience in performing stability testing for all types of commercial and premarket drug products. 

Catalent Benefits 

• Approximately 22,000 sq. ft. of chamber capacity
• Statistical analysis and data trending
• On-time sets and pulls assured by validated LIMS system
• All ICH and regional storage conditions for pharmaceutical and biotech products
• Photostability ICH (Option II)
• Redundant critical systems for power and humidity
• Validated primary and secondary monitoring systems for zero-gaps chamber monitoring

Catalent Services  

We offer a wide range of analytical services:

• Protocol Design
• Long-Term Stability Testing
• Accelerated Stability Testing
• Drug Substance Stability Testing
• Commercial Product Stability Testing
• Comparator Stability Testing
• Formulation Evaluation Stability Testing
• Statistical Analysis and Data Trending
• Forced Degradation Studies
• Photostability
• Temperature Cycling

Catalent Capabilities

• Storage conditions
  • Approximately 22,000 cubic feet of storage area over a broad range of storage conditions 
  • Each stability chamber operating independently with its own temperature and, where applicable, humidity controls
  • All storage chambers continuously monitored by a Kaye Monitoring System and a hardwired security system 
  • Temperature and humidity setpoint windows at 2 degrees C and 5% RH, respectively 
  • All storage chambers fully operational on full generator backup within 6 seconds of power failure
• Photostability
  • Light exposure/temperature control
    • ICH with temperature control and monitoring at 25° C
    • Fluorescence 200-1000 ft. candle
    • Room light/CRT
• Chamber qualifications
  • Kaye Monitoring System (out-of-range alarms and notification)
  • Full generator backup
  • Backup water system
• Types of sample storage
  • Drug product
  • Drug substance
  • Placebo
  • Comparator drug product
  • Controlled drugs