FAQ
Drugs

If a solvent used in drug substance manufacturing process may be contaminated with ICH Q3C class 1 residual solvents (for example., toluene or acetone may contain benzene), what information should be provided if routine analysis of class 1 solvent in intermediates or in final drug substance is expected to be waived?

刊登日期:2020-07-23  |  點閱次數 : 1182 次 

Take one of the following approaches in order to waive routine control of class 1 solvent in intermediates or in final drug substance:

  1. 1. Provide analysis results of class 1 residual solvent for suitable intermediates or final drug substance in 6 consecutive pilot scale batches or 3 consecutive industrial scale batches . Analytical method validation should be provided and analysis results should demonstrate that class 1 solvent concentration in intermediates or final drug substance is less than 30% of acceptable concentration limit as stated in ICH Q3C.
  2. 2. Perform routine analysis of class 1 solvent concentration in the organic solvent used in the manufacturing process and specify the limit of class 1 solvent based on ICH Q3C requirements.

(中文版)


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