Synthesis and Structural Characterization of Process Related Impurities of Mirabegron: A Beta-3 Adrenergic Agonist Drug

Abstract

In the synthesis of active pharmaceutical ingredient and the development of pharmaceutical products, the impurities profiling plays a significant role. The control of impurities is essential for producing the quality, safe and efficient drug products for therapeutic use. Few works reported for the synthesis of potential impurities and further characterized to support the synthesis route and purity of the synthesized compound. Hence in present study, five impurities of mirabegron such as impurity 3, 4, 6, 8 and 9 were synthesized and structural characterization was carried using NMR, IR and mass spectral studies. Based on the results, it was confirmed that the route of synthesis established in the study was simple, convenient and economical and can be useful for the products of potential impurities of mirabegron. By characterizing each of these impurities, the regulatory need has been met. Additionally, the analytical method development and validation studies have utilized the generated impurity standards. This effort helped with the process development’s optimization stage and made it possible to identify the crucial parts of the process. The production method for mirabegron was carefully adjusted to eliminate or reduce the formation of impurities, which is helpful for the creation of safe pharmaceutical goods.