Analysing Impurities and Degradation Products

Abstract

In the realm of pharmaceutical analysis, the analysis of impurities and degradation products takes centre stage, and its significance cannot be overstated. These undesired substances can profoundly impact the quality, safety and efficacy of pharmaceutical products, necessitating rigorous analytical methods and processes at every stage of drug development and manufacturing. Forced degradation studies are instrumental in identifying and characterizing impurities that may arise within a product, a pivotal source of information for quality control and regulatory compliance. Stability testing is integral to the batch release process, ensuring each product batch meets established stability criteria before entering the market. Stability testing and degradation studies are indispensable constituents of pharmaceutical analysis. They substantially contribute to preserving the quality, safety, and efficacy of pharmaceutical products. Beyond their regulatory mandates, these studies serve as proactive instruments for comprehending and supervising product stability across their life cycles. The insights gleaned from these endeavours inform critical judgments during drug development and manufacturing, ultimately assuring the welfare of patients and compliance with stringent regulatory requisites.