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Demonstration Method for Control Limits of Organic Impurity

1, Scientific literature and main metabolite method:

  If the scientific literature has proved that a certain level of an impurity is not a safety concern, then the limit established based on that level does not need further justification.

  In addition, if the scientific literature has proved that an impurity itself is also the main metabolite of the drug substance metabolized in the body, its safety is obvious, so even if the impurity is set a limit higher than the ICH demonstration limit, it can usually be considered that the impurity is reasonably controlled.

2, Toxicology studies:

  Due to the time-consuming and high cost of toxicology experiments, this method is generally adopted when other methods cannot reasonably research and demonstrate impurities. This study can be conducted directly with the API or the formulation containing the impurity, or with the isolated impurity.

3, Comparative analysis:

  The impurities of the API in the generic drug application can be compared with the approved reference formulation using the same validated analytical method to demonstrate that the quality is better than or comparable to the marketed drug.