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欧洲药典8.0 多晶型现象 中英文

上传者:苏堤漫步 |  格式:doc  |  页数:6 |  大小:19KB

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e tools for fully understanding the energetic relationship (enantiotropism, monotropism) and the thermodynamic stability of the individual modifications of a pound.Р 根据分析数据绘制的压力/温度图和能量/温度图有利于充分理解能量关系(互变现象,单变现象)和多晶型化合物单变量调整的热力学稳定性。Р For solvates, differential scanning calorimetry and thermogravimetry are preferable, combined with measurements of solubility, intrinsic dissolution rate and X-ray diffraction.Р 对于溶剂化物,最好选择差示扫描量热法和热重分析法,同时结合溶解度、固有溶出速率和X-射线衍射的测定。Р For hydrates, water sorption/desorption isotherms are determined to demonstrate the zones of relative stability. In general, hydrates are less soluble in water than anhydrous forms, and likewise solvates are less soluble in their solvent than unsolvated forms.Р 对于水合物,通过测定水吸附/脱附的等温线可以得到相对稳定的区域。一般来说,无水形式比水合物更易溶解于水,同样非溶剂形式也比溶剂合物更容易溶解在其溶剂中。

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