Stability Testing
An understanding of the stability of compounds and formulated products is a key element in providing safe and effective products, and is the subject of much regulatory attention.
Primera’s experts can provide the essential elements necessary to assure regulatory compliance and successful product development.
Primera’s stability testing program is backed by a robust system of SOPs and are fully complaint with GLP programs.
Stability chambers are backed up with generator power and are fully alarmed. The alarms are connected to a 24/7 system of cell phone notification, assuring that any outages will be promptly addressed.
The stability program includes the development of stability indicating methods, conduction of forced degradation studies, and the sampling of products maintained in ICH complaint conditions.
Extra chambers are available to clients seeking stability information at conditions other than those indicated by the ICH.
Primera has photostability chambers in addition to temperature and humidity chambers.
Primera conducts stability testing of tablets and capsules, oral liquids, dermatological formulations, API’s, and packaged products.
Primera is also capable of studying the stability of products in physiological and simulated physiological fluids.