When class 2 solvents are used in the manufacturing process of drug substance, what information should be provided if the absence of a routine test for class 2 solvents in the drug substance?

刊登日期:2019-11-12  |  點閱次數 : 37 次 

The following information should be provided. For details, please refer to CPMP/QWP/450/03 Rev. 1 “Annexes I: specifications for class 1 and class 2 residual solvents in active substances”.

  1. (1)  A class 2 solvent is used in the last step of a synthesis it should be routinely controlled in the drug substance.
  2. (2)  Class 2 solvents used prior to the last step in the synthesis have not to be included in the drug substance specification if it has been demonstrated, on a suitable intermediate or on the drug substance, that the content of class 2 solvents is not more than 10% of the acceptable concentration limit stated in ICH Q3C. To support the absence of a routine test for class 2 solvents in the drug substance or in the suitable intermediate, results of the content of class 2 solvents should be presented from 6 consecutive pilot scale batches or 3 consecutive industrial scale batches of the suitable intermediate or the drug substance.



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