Stability Services
Azopharma provides stability programs to support early development through lot expiration verification.
A summary of our storage and stability testing capabilities includes:
- Active Pharmaceutical Ingredients (APIs)
- Finished products
- R&D preliminary stability (protocol development, testing and evaluations)
- Clinical Trial Material (CTM)
- Photostability of API
- Walk-in and reach-in units
- Customized cycling conditions
- Continuous monitoring and alarming (Kaye Labwatch™)
- Site Backup Generator
- Data trending
- Expiration trending
We provide stability storage under ICH guidelines for a variety of storage conditions:
| Temperature (Celsius) | Humidity |
| 5° | Controlled Humidity |
| 25° | 60 |
| 25° | 40 |
| 30° | 35 |
| 30° | 60 |
| 30° | 65 |
| 40° | 75 |
| 40° | <25 |
| 60° | Ambient |
*Additional conditions can be provided on an as needed basis including alternate storage conditions for Climatic Zones III and IV such as 30ºC/75%RH