Stability Studies – Pharmaceutical

Stability Studies – Pharmaceutical

Stability Studies for pharmaceuticals are essential for the development and maintenance of a safe and effective drug product. During medication development, testing for stability is conducted to ensure the medication will remain effective throughout its life cycle. Additionally, a formal stability evaluation is done to investigate any potential forced degradation that may occur during the drug’s shelf-life. To comply with ICH guidelines, testing for photostability is also conducted.

When testing for stability, unidentified degradation products and impurities can be found and verified via stability-indicating techniques. Furthermore, batch registrations and ongoing stability testing are also conducted. For over a decade, analysis of stability samples has been done to evaluate leached contaminants and their interactions with drug matrices. This combination of fundamental stability testing and extractable/leachable offers a more comprehensive assessment of a drug product.

To expedite projects, stability, and leachable programs are often done in tandem. This allows for the identification and synthesis of unknowns, enabling the quantitative monitoring of stability and/or leachable projects.

Video 01: Forced Degradation Stability Study in Pharmaceuticals