Analytical Services
Stability Services
EAG Life Sciences' stability storage program adheres to the highest level of quality and compliance. We offer all standard FDA/ICH recommended conditions, as well as customized conditions to meet product-specific needs. Our stability testing services are the perfect complement to any stability storage program. From development to commercialization, we can provide the testing to take your product to the next level.
Stability Storage
- Walk-in & Reach-in Chambers
All environment chambers at EAG undergo rigorous qualification procedures including routine temperature mapping.
Darwin Walk-in Chamber Conditions
| Temperature | Relative Humidity |
| 25 °C | 60% |
| 30 °C | 65% |
| 40 °C | 75% |
| Customized Temperature | Customized Humidity |
Luwa Reach-in Chamber Conditions
|
- Continuous monitoring with phone notification (Kaye Labwatch™)
In addition to local alarms, each chamber is monitored 24 hours a day by a wireless temperature/humidity tracking system. Should any chamber go out of specification, the system notifies appropriate personnel via telephone. The entire system undergoes comprehensive annual calibration/qualification by the manufacturer. The telephone notification system is verified on a monthly basis to ensure the integrity of your study.
- Limited/Controlled Access
The stability chambers are located in a key-card protected area of the building with limited access. Chambers are kept locked at all times, and each entry is meticulously documented in chamber access logs.
- Site Back-up Generator
EAG Life Sciences' building is equipped with a back-up generator that can provide electricity to the entire site, ensuring your product is never at risk during a power outage.
Stability Testing
Our staff has experience with every phase of the drug development process, and can work with you to create an experimental protocol for your product's needs. We offer many different analytical techniques, such as HPLC, LC/MS, GC/MS, and ICP/MS. See our Instrumentation page for more details.
- R & D Preliminary Stability
- Active Pharmaceutical Ingredients (API)
- Clinical Trial Material (CTM)
- Finished Products
- Data & Expiration Trending
