As a supportive service piCHEM offers stability studies according to ICH guidelines for APIs and drug products including long-term stability testing, accelerated stability testing and forced degradation testing/stress tests.
The services are performed under GMP conditions. The design of the studies is based on individual needs and agreed by the customer prior to start. Analytical measurements are performed using appropriate, robust methods to detect new degradation products. Data are reported to the customer in interim and final reports and are implemented in regulatory affairs dossiers where required.
All incubation areas/ stability chambers (-20°C, 5°C and 25°C) are equipped with a 24/7 alarm system and an emergency backup generator.