Stability and Release Testing
BSM will work with your analytical team to develop stability protocols that are specific to the needs of your study. We design these with set pull points, incubation temperature, and testing requirements for each pull point. A final report will be provided at the end of each study but the client can receive interim reports throughout the stability study after review and approval from our quality department. Below are listed the validated chambers that BSM currently has available to clients for storage. If a client needs and additional temperature point that is not included below, BSM can install, map and validate new chamber(s) as needed. We work closely with the client and our quality department to ensure that your study is designed to give you the most effective measures of your drug’s stability. We pride ourselves on flexibility and responsiveness in designing and monitoring your stability studies, while keeping the integrity of your data at the highest level.
|25° +/- 2°||60% +/- 5%||Walk-in 8’x10′|
|40° +/- 2°||60% +/- 5%||150 sq. ft.|