Storage and stability testing is not only a regulatory requirement but a critical aspect of ensuring the highest standards of product integrity and patient care. It plays a crucial role in protecting patient health by establishing the appropriate shelf-life, storage conditions, and labeling instructions.

Our lab provides a range of temperature and humidity options for stability studies. For ICH conditions climate cabinets are available and are continuously monitored by automated monitoring systems with full back-up of data and power supply. Customized temperature and relative humidity conditions can be accommodated upon request. If required, we can also offer expert guidance in designing studies tailored for various conditions.

Testing at different timepoints during storage is a key aspect in which we can assist utilizing the capabilities within our laboratory. Furthermore, the development and validation of methods that assess critical parameters across different climatic zones is also possible. Our analytical control focuses on monitoring critical stability parameters, ensuring your products meet the highest standards of quality and compliance.

Available climate cabinets:

• 25°C/60%RH
• 30°C/65%RH
• 30°C/75%RH
• 40°C/75%RH

Would you rather require a lot of storage space or special studies, like freeze-thaw, in-use, forced degradation or photostability? Our GMP network of laboratory sites can offer everything you need.