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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