How will my product perform over the long term … after sitting for weeks on the shelf, or in extreme temperatures during shipping? Will it perform to standard necessary for GMP drug or biologic stability analyses?
These are the questions we help our clients answer with our pharmaceutical stability testing and storage facilities. Our skilled scientists use controlled storage facilities and state-of-the-art instrumentation to include GC, HPLC, LC-MS, spectrophotometry, wet chemistry. We constantly monitor your product for how it reacts to temperature, humidity, and light over time, and carefully determine when these factors have an impact on your product’s efficacy. The resulting data helps us set a shelf life for your product, and establishes the basis for storage protocols and manufacturing procedures. Stability testing is a critical step in product development and GMP product certifications. It is also a critical part of the turnkey service we offer to clients.
Exelead performs the following GMP stability analyses:
We offer analytical pharmaceutical stability programs that test how a product degrades over time, measuring its purity, potency, degradation products, and molecular characteristics. Drug and biologic stability testing can be performed under ambient temperature, accelerated conditions, intermediate conditions, and long-term storage conditions.
Sample Stability Chambers
We offer ICH, Cycling, and Customized storage conditions. All chambers are validated and monitored 24/7 for temperature and humidity control.
You can start the proposal process online