What information should be included in the DMF/API application data for a starting material that is commercially available?

刊登日期:2020-07-23  |  點閱次數 : 950 次 
  1. 1. In general, no additional information is required to justify the use of a commercially available chemical as a starting material. However, basic information and impurity profile of the starting material along with how control strategy of the drug substance manufacturing process justifies the starting material specification should still be provided.
  2. 2. Basic information for a commercially available starting material includes chemical name, chemical formula and molecular weight. Specification for the starting material, in order to justify the controls for actual and potential impurities derived from the upstream process, should be determined based on scientific knowledge and available information.
  3. 3. In situations where additional purification steps on the starting materials are required to ensure the quality of a commercially available starting material, it is recommended that these additional purification steps should be included in Section 3.2.S.2.2. (Referenced to ICH Q11 Q&As 5.14) .


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