Displaying 1 results of Nitisinone Impurities Nitisinone Impurities are the unwanted substances that may be present in Nitisinone drug substance or drug product. These impurities can arise during the manufacturing process or through degradation of the drug over time. The identification, characterization, and control of these impurities are critical to ensure the safety, quality, and efficacy of Nitisinone drug products. Regulatory agencies have set limits for these impurities and require their monitoring and reporting during drug development and manufacturing.