Should physicochemical properties of drug substance be provided in technical documentation of the drug substance?

刊登日期:2019-11-12  |  點閱次數 : 372 次 

Yes, physicochemical and other relevant properties of the drug substance, such as appearance, melting point, boiling point, solubility, specific optical rotation, crystalline form, hygroscopicity, pH, acid dissociation constant (pKa), solvates (hydrate), isoelectric point (pI), etc. should be described in 3.2.S.1.3. If the drug substance is biologically active, the relevant properties of the drug substance should be provided.



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