FAQ
Drugs

For starting materials that are not commercially available, what information should be provided on the production of starting materials?

刊登日期:2020-07-22  |  點閱次數 : 741 次 

Information on how the proposed starting material is synthesized (e.g., a flow chart of the starting material manufacturing process, showing all reagents, catalysts and solvents used) should be provided to justify the starting material specification. Evaluation of actual and potential impurities in the proposed starting material should be included.

 

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