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What are the requirements for acceptance criteria of residual solvents in a drug substance applied for a registration of a medicinal product?

刊登日期：2019-11-13  |  點閱次數 : 1220 次 

The acceptance criteria of the residual solvents in the specification of the drug substance can be set according to ICH Q3C. If the solvents used in the manufacturing process are not included in ICH Q3C, an adequate safety data shall be provided to support the acceptance criteria of the residual solvents.

 

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