If the long-term and accelerated stability data in low humidity condition of aqueous-based products packaged in semi-permeable containers were provided, should water loss evaluation still be assessed?

刊登日期：2019-11-22 | 點閱次數 : 1493 次

Yes. The influences among package materials, water loss, and assay during the shelf-life should be evaluated. The water loss evaluation in low humidity condition is still required. Please refer to “Guideline on Stability Testing of Drug Substances and Products” (Chapter 3.3(2)(E)) and ICH Q1A (2.2.7.3 Drug products packaged in semi-permeable containers).

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Drugs Medical Devices Consultation Services Health Technology Assessment International Cooperation

If the long-term and accelerated stability data in low humidity condition of aqueous-based products packaged in semi-permeable containers were provided, should water loss evaluation still be assessed?

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