Challenges of Synthetic Organic Drug Development

Abstract

This research paper delves into the critical area of synthetic organic drug development, with a particular focus on impurity profiling. The pharmaceutical industry's commitment to producing high-quality and safe medications is emphasized, as well as the significance of analytical methods and their validation. Impurities, their sources, and the impact of impurity levels on drug safety are explored. The study presents a literature review of research work in the field, highlighting the development and validation of methods for drug quantification. The research topic and objectives are outlined, and the research methodology, including instrumentation, solvents, and data collection, is described in detail. Method validation parameters, the perspectives of the present research, and the scope and limitations are discussed. The importance of this research in maintaining drug quality and purity is underscored, especially in the context of impurity profiling.