ADVANCES IN CHROMATOGRAPHIC SEPARATION METHODS FOR FORCED DEGRADATION PRODUCT ANALYSIS

Abstract

Putting new pharmaceutical compounds and finished pharmaceutical goods through a process of "forced degradation" involves subjecting them to more extreme conditions than "accelerated degradation." Procedures that indicate stability must be shown to be particular. It also helps in understanding the structure of the degradation products and provides insight into the paths and products of the therapeutic substance's deterioration. In order to help with the development of formulation and packaging, forced degradation studies may be used to ascertain the molecule's chemical behavior. To add insult to injury, the regulatory guidance is very nebulous and offers zero details about how forced degradation experiments should be conducted. Hence, the present trends in forced degradation research performance are the focus of this work. In order to achieve this goal, a study design is provided, the reasons of deterioration are detailed, and analytical approaches that aid in the development of stability indicating methods are detailed.