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On the API Registration and DMF Refuse to File (RTF) checklist, what information must be provided for the starting material at the minimum?

刊登日期:2021-11-17  |  點閱次數 : 215 次 

(1) Name of manufacturer, specification and certificate of analysis (or analysis results) of starting materials must be provided. At the RTF stage, certificate of analysis from either the vendor or API manufacture is acceptable and only one of those is required. If several starting materials are used in the API synthesis, certificate of analysis or analysis results must be provided for each starting material.

(2) The starting material(s) chosen for the manufacturing process must be indicated. In addition, sections of ICH Q11 and ICH Q11 Q&A related to starting material selection should be referenced in providing the rationale and supporting information for selection of starting material(s). In principle, a starting material must not be chosen in such a way that API may be obtained from only a single purification or salt-forming step from the starting material.

 

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