What information on impurities in the drug substance should be included in CTD Section 3.2.S.3.2 when submitting a DMF/API application?

刊登日期:2020-07-22  |  點閱次數 : 769 次 

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.


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