Abstract

Practically Implementing Forced Degradation Studies for Drug Product Development

Markus Zimmer, Head, SANOFI

Forced degradation is one of the most chosen methodologies to check the suitability and limitation during method development and validation for active pharmaceutical ingredients (API). In the final (commercial) formulation, there are a lot of excipients to make the API producible and bioavailable. Most of the excipients used are not inert from a chemical point of view and therefore, destabilization can occur caused by several mechanisms of degradation. In order to be predictable for long-term storage results regarding the drug product (DP), it is important to choose the most appropriate approach(es) and conditions for forced degradation to avoid any surprises at later stage of development or submission.