Paper Key : IRJ************213
Author: Mr. Arun Sathe
Date Published: 01 Oct 2023
Abstract
New medicinal components and products degrade quicker under accelerated circumstances than in normal ones. It proves stability-indicating methods work and reveals the drug's breakdown and final form. It also helps show breakdown product pieces. Forced degrading tests novel pharmaceutical compounds and medical items under stricter conditions than quick degrading tests. These studies show that the molecule is chemically stable, enabling consistent, reproducible formulations. The International Council for Harmonization (ICH) lists irradiation, oxidation, dry heat, acids, bases, and hydrolysis as degradation causes. All of these causes may occur alone or together. The gold standard for forced decline testing is ICH Q1A, QIB, and Q2B. Forced breakdown testing may reveal a molecule's chemical behavior, helping create new formulations and packaging. The regulatory rule is unclear concerning forced decline study technique. This study reviews how forced degradation research has shaped scientific methods. This document highlights their contributions.