areta has an extensive experience in stability studies. areta can design and carry out long-term, intermediate and accelerated stability study protocols of process intermediates, drug substances and drug products. The stability studies are conducted according to ICH guidelines. Stability samples are stored under controlled temperature and humidity (-80°C, -20°C, 2-8°C, 25°C/60%RH, 30°C/65%RH, 40°C/75%RH).

The samples are analyzed according to the protocol at each defined time point and a final report is issued at the end of the study. areta stability chambers are qualified by IQ/OQ and PQ and are continuously monitored for temperature and humidity values.