Tezacaftor impurities are the unwanted substances that may be present in Tezacaftor drug substance or drug product. These impurities can affect the quality, purity, and safety of the drug. Therefore, it is essential to identify, monitor, and control these impurities during the manufacturing process to ensure that the drug meets the regulatory requirements and is safe for human use. Tezacaftor impurities can be categorized into organic, inorganic, and residual solvents. The identification and quantification of these impurities are critical for the development and validation of analytical methods for quality control purposes.
