If a drug substance may contain different numbers of solvated water (ex: anhydrous, hemihydrate, monohydrate or dihydrate forms), is it required to denote the numbers of solvated water in the name of the drug substance?

刊登日期：2020-07-22 | 點閱次數 : 812 次

Yes, the numbers of solvated water should be denoted in the drug substance name in the application in order to differentiate between drug substances containing different solvated water.

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Drugs Medical Devices Consultation Services Health Technology Assessment International Cooperation

If a drug substance may contain different numbers of solvated water (ex: anhydrous, hemihydrate, monohydrate or dihydrate forms), is it required to denote the numbers of solvated water in the name of the drug substance?

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