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客户要求我们提供资料做原料药DMF注册,比如我们提供的产品(A)到最终客户API有两步反应,产品(A)本身有3步反应,客户要求供应商提供A产品的3个起始原料的详细工艺资料,主要如下表,想知道是否合理,有无参考资料或相关法规可以学习,感谢赐教( c$ P# }% o; `. E, v, P& v
1. | Spec/STP/COA of Stating material including related substances (specified and un-specified) with total impurities and residual solvents. | | Stage-wise ROS of Stating material including all raw materials (reagents, Solvents, catalyst etc.) | | Stage-wise Process flow of Stating material including all raw materials (reagents, Solvents, catalyst etc.) used in the process flow | | Stage-wise brief manufacturing process of Stating material | | List of raw materials stage wise by categorise like reagents/ solvents/ metal catalysts/ filter aids etc. | | List of possible impurities and solvents |
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