Isolation Identification and Characterization of Unknown Impurities in the Active Pharmaceutical Ingredients

Abstract

Introduction to Pharmaceutical Impurities, Analytical techniques for impurity analysis, Analytical Method Development and Validation newline newlineQuality, purity, safety and efficacy of pharmaceuticals are the fundamental issues of importance in drug therapy. A greater emphasis is being paid today on assurance of the quality and safety of a drug by monitoring and controlling the impurities and degradation products. The control of pharmaceutical impurities, unwanted substances is a critical issue for the pharmaceutical industry since their presence in the active pharmaceutical constituents and its dosage forms diminish both drug quality and safety. By the identification or characterization and quantification of the impurities and related substances, the risk of their contribution to the side effect profile of the drug therapy can be avoided or minimized. Hence, the development of new analytical methods became an essential task for investigators to determine the stress-related impurities along with their degradation pathway. A forced degradation study (stress testing) is the main tool used to predict stability problems, develop analytical methods, and identify degradation products. In the recent years numerous innumerable research papers have been published on this subject dealing with HPLC, UPLC, LC-MS/HRMS to emphasize impurity profiling as a hot topic in contemporary pharmaceutical analysis. Isolation and Spectral Characterization of Degradation Impurity in Perampanel Drug Substance Using UPLC-MS