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.

(中文版)

	Is there any facilitated regulatory pathway of drug registration in Taiwan?
	Is it allowed to use a nonspecific method such as loss on drying to control resid

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Drugs Medical Devices Consultation Services Health Technology Assessment International Cooperation

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?

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