Our Services

Forced Degradation Studies and ICH Stability Programs

Avatar has years of experience in providing high-quality support for forced degradation and stability projects. Forced degradation studies are critical in determining whether a particular test method is capable of indicating stability. To ensure client stability study success, Avatar offers comprehensive forced degradation programs. These studies not only provide a greater understanding of material degradation pathways under various environments, they also impart a greater confidence in the reliability of the results, thereby enhancing the quality of FDA submissions.

We offer individually designed forced degradation studies that can be implemented prior or in parallel to ICH stability testing. Our studies incorporate acid, base, thermal, oxidation, and photoexposure conditions – individually or in multiple combinations. The resulting degradation products may be characterized by mass spectroscopy.

For stability study design, storage, project management, analytical testing and documentation, Avatar offers ICH or customized services to meet your needs. By working in close collaboration with clients and employing our wealth and diversity of experience and resources, we develop stability programs designed to reduce costs and expedite time to market.

Our stability programs (storage and testing) are performed in fully mapped and validated environmental chambers that are complete with redundancy and emergency power generation. To ensure material integrity, the chambers are electronically monitored 24 hours a day, seven days a week.