Throughout the product life cycle, we provide ICH-compliant stability programs, comprehensive stability testing, and sample storage that accommodates both standard temperature ranges and special product requirements.
Stability is a key focus of our analytical scientists. They carefully evaluate both APIs and drug products under a variety of conditions, assessing their shelf-life, collecting regulatory data, establishing optimal storage conditions, and defining shipping and distribution parameters.
Our experts can conduct these stress-tests using a broad portfolio of analytical methods:
Whether your product is in clinical development, under regulatory review, or on the market, we monitor and verify its stability at multiple points throughout its life cycle.
In-line stability studies are typically conducted:
When we perform our stability studies specified by our customers, we consider and test a variety of different temperature ranges, humidity levels, and lighting conditions.
The climate zones available at Vetter range from moderate, to subtropical, to dry heat, to intense heat. We can test in temperatures from 25° to 40°C with various levels of relative humidity, as well as cold and freezing storage conditions ranging from +2°C to -80°C.
