Crystal Pharmatech has a number of stability chambers ready for your short or long-term stability needs. Both API and formulated products have been included in our stability programs.
A variety of both accelerated and strong conditions are available at:
40°C/75%RH
30°C/65%RH
25°C/60%RH
5°C/amb%RH
Both chemical and physical stability are investigated using state-of-the-art equipment for analysis. Based on our many years of pharmaceutical experience, we can run your analytical method or develop and validate an analytical method to fit the bill. Studies will be set-up to support the initial re-evaluation date as well as extend the shelf-life for your drug product. All stability studies are captured in a detailed report that can be readily incorporated into regulatory documents. If changes occur during the stability study, our scientists can go the next step with additional studies to find the cause and recommend solutions. Whether it is a simple short term study or a complex long-term study, Crystal Pharmatech has the knowledge and expertise to get it done correctly the first time.