We work with your analytical team to develop stability protocols that are specific to the needs of your study and will give you the most effective measure of your drug’s stability. We design these with set pull points, the temperature of incubation, and testing protocol for each pull point. A final report will be provided at the end of each study time-frame but you will receive interim reports throughout the stability studies with a review and sign off from our quality department. Our validated chambers we have available for storage are listed below, but if you need an additional temperature point, then SSM will purchase, install, map, and validate the new chamber on request.
SSM has the latest technology in environmental stability and photostability chambers. These are monitored remotely 24/7, and they are placed on generators with an alarm based system to protect the integrity of your drug program. BSM provides -80°C, -20°C, 2-8°C, 25°C ± 2°C (60% RH ± 5% RH), 40°C ± 2°C (75% RH ± 5% RH) chambers for your product stability assessment.
Stability Programs available
- Clinical trials
- Commercial
- NDA
- BLA
- ANDA
- IND
What we offer
- Protocol Generation
- Stability Testing
- Storage
- Interim Reports
- Summary report generation
- Preclinical – Clinical stability
Available Stability Chambers
- -80°C
- -20°C
- 2-8°C
- 25°C ± 2°C (60% RH ± 5% RH)
- 40°C ± 2°C (75% RH ± 5% RH)
