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• Application

  Impurity research is a crucial aspect of drug development. It involves selecting appropriate analytical methods, accurately identifying and measuring the content of impurities, and determining reasonable limits for impurities by integrating the results of pharmaceutical, toxicological, and clinical studies. This research is conducted throughout the entire drug development process. Adverse reactions in clinical use are related not only to the pharmacological activity of the drug itself but also to impurities within it. For example, polymers and other high-molecular-weight impurities in antibiotics such as penicillin are a major cause of allergies. Therefore, conducting standardized impurity research and controlling impurities within a safe and reasonable range directly affects the quality and safety of marketed drugs. Trimetazidine impurity F can be used in the standard setting process during trimetazidine development. During the development of generic trimetazidine drugs, a detailed quality study of marketed products of the same type is necessary, analyzing the types of impurities, including trimetazidine impurity F and its content, and conducting a comprehensive quality comparison with the product under development. Based on this, impurity limits, including limits for trimetazidine impurity F, are then established for the product under development.;

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