application | impurity research is an important part of drug research and development. It includes selecting appropriate analysis methods, accurately distinguishing and determining the content of impurities, and combining the results of pharmaceutical, toxicological and clinical studies to determine the reasonable limit of impurities. This research runs through the whole process of drug research and development. Because the adverse reactions produced by the drug in clinical use are not only related to the pharmacological activity of the drug itself, but also related to the impurities in the drug. For example, polymeric impurities such as polymers in antibiotics such as penicillin are the main causes of allergies. Therefore, conducting research on impurities in a standardized manner and controlling impurities within a safe and reasonable range will directly affect the quality and safety of marketed drugs. Misazide is an intermediate for the synthesis of mirtazapine. It can be used in the standard formulation of mirtazapine in the development process. During the development of mirtazapine generic drugs, the quality of the same product that has been on the market should be studied in detail. Analyze the types of impurities including misazide and its content, and conduct a comprehensive quality comparison with the products under development, and then formulate the impurity limits of the products under development based on this, including the limit of tramine cyanide. |