Is it allowed to use a nonspecific method such as loss on drying to control residual solvents in the active pharmaceutical ingredient (API) when only Class 3 solvents are used in the API manufacturing process?
刊登日期:2020-07-23 | 點閱次數 : 1317 次
Yes, if only Class 3 solvents are present in the API, a nonspecific method such as loss on drying may be used.
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