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Stability Testing And Storage
Catalent Pharma Solutions
Catalent's scientists have years of experience in performing stability testing for all types of commercial and premarket drug products, from placebos to controlled drugs. They offer standard storage conditions, meeting ICH guidelines, along with any specialized storage conditions your product may require.
Analytical services:
- Protocol Design
- Long-Term Stability Testing
- Accelerated Stability Testing
- Drug Substance Stability Testing
- IND, NDA, ANDA Stability Testing
- Commercial Product Stability Testing
- Comparator Stability Testing
- Formulation Evaluation Stability Testing
- Statistical Analysis and Data Trending
- Forced Degradation Studies
- Photostability
- Temperature Cycling
Storage:
- Catalent Pharma Solutions offers approximately 22,000 cubic feet of storage area over a broad range of storage conditions.
- Facility in Research Triangle Park, NC has 37 chambers, which includes 16 walk-in chambers.
- Facility in Somerset, NJ has 19 chambers, which includes 4 walk-in chambers.
- Facility in San Diego, CA has 19 chambers, which includes 8 walk-in chambers
Each stability chamber operates independently with its own temperature and, where applicable, humidity controls. All storage chambers are continuously monitored by a computerized Kaye Monitoring System and a hardwired security system. Temperature and humidity setpoint windows are 2 degrees C and 5% RH, respectively, and failures outside setpoint ranges result in an immediate alert to the stability staff. Additionally, all of our storage chambers are on full generator backup in case of power failure. Backup power is fully operational within 6 seconds of power failure.
