Synthesis and Analysis of Impurities in Pharmaceutical Products

Such components that diminish the purity, potency, quality, quantity or the expected standard of the intended component, termed as the active pharmaceutical ingredients(APIs) are subsequently termed as Impurities. These impurities are the undesired compounds that are remnant in the active pharmaceutical ingredients (APIs), at some point in the manufacturing process, or while putting together the active drug ingredient into the finished drug/medicine or upon preservation of the active pharmaceutical ingredient or medication product/medicines. The presence of these Impurities even at trace level might have a serious impact on the efficacy or the safety of the pharmaceutical product(s). Control and probable elimination of these impurities in the pharmaceutical drug substances becomes the primary goal of drug development i.e., presence of undesirable substances, even in trace amounts, This may have an impact on the drug's efficacy and safety is also equally gaining Importance in Pharmaceutical Industry.