The control of impurities plays a significant role for the production of high quality drug substance. In the present study, we reported a simple four step route for the synthesis of desfluoro impurity (4-(3-(4-cyano- 3(trifluoromethyl) phenyl dimethyl-2,4- dioxoimidazolidin-1-yl)-N-methyl benzamide) of enzalutamide drug with readily available raw materials and intermediate chemicals. The synthesised compound was characterized using FT-IR, NMR and mass spectral studies. Based on the spectral analysis, it was confirmed that the compound was pure with no other bye-products or side reactions formed in the synthesis route. The purity and quantity of the compound were further evaluated using HPLC analysis. Based on the HPLC analysis, it was confirmed that the compound is having a purity of 98.58 %. Hence it can be concluded that the proposed route of methodology produces highly pure compound that can be utilized as reference substance and are useful for quality control and the validation of the analytical method in the manufacture of enzalutamide.

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.