If only Class 3 solvents are used in themanufacturing process of active pharmaceutical ingredient (API) and the loss on drying (LOD) test result is more than 0.5%, should the Class 3 residual solvents be controlled individually?

刊登日期:2020-07-23  |  點閱次數 : 990 次 

Yes, if only Class 3 solvents are present in the API and the LOD test result is greater than 0.5%, the individual Class 3 residual solvents present should be identified, quantified and controlled.



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