1. 1. If the impurity has been listed in the pharmacopoeia and complies with the limit, the structural characterization and/or safety data of the impurity is not required. If the impurity is not listed in the pharmacopoeia, please refer to ICH Q3A to provide the relevant data (e.g., the structural characterization data as the limit is higher than the identification threshold and the safety data as the limit is higher than the qualification threshold).
2. 2. Types of impurities, structural characterization data and batch analysis data (including clinical, non-clinical, stability data, etc.) should be provided in 3.2.S.3.2 with explanations on whether these impurities are listed in the specifications.

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