Difluprednate Impurities are chemical substances that are present in difluprednate drug substance or drug product that are not the intended active ingredient. These impurities may arise during the manufacturing process or storage of the drug product. It is important to identify and control these impurities as they may affect the safety, efficacy, and quality of the drug product. Analytical methods are used to detect and quantify these impurities, and their limits are set by regulatory agencies.