Abstract

FORCED DEGRADATION STUDIES AND CHARACTERIZATION OF DEGRADATION PRODUCTS OF ACTIVE PHARMACEUTICAL INGREDIENTS (API)

Zaid Ansari and Anwar R. Shaikh*

ABSTRACT

Forced degradation studies serve multiple purposes: they aid in developing analytical methods, enhance understanding of the stability of active pharmaceutical ingredients (APIs) and drug products (DPs), and provide insights into degradation pathways and products. Drug stability is a crucial factor that can impact purity, potency, and safety. This review explores the forced degradation of active pharmaceutical ingredients (APIs) and characterization of their degradation products using microscale techniques as well as various spectral techniques. Forced degradation is a vital part of stability testing which simulates environmental stresses such as heat, light, and moisture, to assess the chemical integrity of APIs under extreme conditions.

Keywords: Forced degradation studies, Microscale Techniques, Characterization, degradation products, different spectral techniques.