The following information should be included：

1. 1. The origins, control strategies, analysis data, analytical methods, historical analysis data of related substance (process-related impurities and degradation products) should be provided. In addition, information on residual solvents, reagents, elemental impurities, and potentially genotoxic/mutagenic impurities that are observed and/or generated in the manufacturing process and during storage period should be provided.
2. 2. The structural elucidation data of specified impurities listed in drug substance specification should be provided.

(中文版)