Darolutamide Impurities are substances or compounds that are present in Darolutamide drug substance in small amounts. These impurities may be formed during the manufacturing process or can be introduced during storage or transportation. It is important to identify, monitor, and control these impurities as they can affect the safety, efficacy, and quality of the final product. The characterization and quantification of these impurities are crucial for the regulatory approval of Darolutamide drug substance.