Stress Induced Degradation Study of Marketed Formulation of Selected Drug

Abstract

A study of stress-induced degradation, sometimes referred to as forced degradation, is an -essential component of quality assurance and medication development. This study set out to examine the stress-induced degradation behavior of a commercially available formulation of Paracetamol is a commonly used medication. Analytical techniques such as high-performance liquid chromatography (HPLC) were employed to quantify the extent of degradation and identified degradation product. It's done to learn about a pharmacological substance's intrinsic stability and stability degradation processes For regulatory formulation under a variety of stressful circumstances. submission these investigations are also necessary to guarantee safety, effectiveness, and shelf life. In order to ensure the safety, effectiveness, and quality of marketed medication formulations stress testing is a vital part of pharmaceutical development. In these investigations, the drug substance and/or drug product are subjected to extreme circumstances in order to identify the degradation product and initiate a potential degradation route.  For both pharmacological substances and goods, a forced degradation study is a crucial element in creating a stability program that complies with regulations. This standard was established in 1993 by ICH guideline Q1A.Since then, it has been expanded to include generic medication. We give an update on global regulations that are necessary.