weigh weight 区别
各国药典(EPUSPCP)溶解性差异比较
3个质量标准对于溶解性的定义很接近,除了细节的区别的外。限度的规定中EP是包含后一个的体积,而USPChP2020是不包含后面的体积。EP和ChP2020的具体试验方法和试验温度要求也有差异,USP中未明确具体操作。
序号
EP10.8
USP 
ChP2020
定义
描述
定义
描述:1份溶质所需要溶剂的份数
定义
描述
1
Very soluble
Weigh 100mg of finely powdered substance  in a stoppered tube (16 mm in internal diameter and 160 mm long), add 0.1 mL of the solvent and proceed as described under Dissolving Procedure. If the substance is completely dissolved, it is very soluble.
Very soluble
Less than 1
极易溶解
溶质1g(ml)能在溶剂不到1ml中溶解
2
Freely soluble
If the substance is not completely dissolved, add 0.9 mL of the solvent and proceed as described under Dissolving Procedure. If the substance is completely dissolved, it is freely soluble.
Freely soluble
From 1 to 10
易溶
溶质1g(ml)能在溶剂1~不到10ml中溶解
3
Soluble
If the substance is not completely dissolved, add 2.0 mL of the solvent and proceed as described under Dissolving Procedure. If the substance is completely dissolved, it is soluble.
Soluble
From 10 to 30
溶解
溶质1g(ml)能在溶剂10~不到30ml中溶解
4
Sparingly soluble
If the substance is not completely dissolved, add 7.0 mL of the solvent and proceed as described under Dissolving Procedure. If the substance is completely dissolved, it is sparingly soluble.
Sparingly soluble
From 30 to 100
略溶
溶质1g(ml)能在溶剂30~不到100ml中溶解
5
Slightly soluble
If the substance is not completely dissolved, weigh 10 mg of finely powdered substance  in a stoppered tube, add 10.0 mL of the solvent and proceed as described under Dissolving Procedure. If the substance is completely dissolved, it is slightly soluble.
Slightly soluble
From 100 to 1000
微溶
溶质1g(ml)能在溶剂100~不到1000ml中溶解
6
Very slightly soluble
If the substance is not completely dissolved, weigh 1 mg of finely powdered substance  in a stoppered tube, add 10.0 mL of the solvent and proceed as described under Dissolving Procedure. If the substance is completely dissolved, it is very slightly soluble.
Very slightly soluble
From 1000 to 10,000
极微溶解
溶质1g(ml)能在溶剂1000~不到10000ml中溶解
7
Practically insoluble
If the substance is not completely dissolved,  it is very slightly soluble.
Practically insoluble, or insoluble
10,000 and over
几乎不溶或不溶
溶质1g(ml)在溶剂10000ml中不能完全溶解
8
试验法
Shake vigorously for 1 min and place in a constant temperature device, maintained at a temperature of 25.0 ± 0.5 °C for 15 min. If the substance is not completely dissolved, repeat the shaking for 1 min and place the tube in the constant temperature device for 15 min.
试验法
未规定,可参考EP
试验法
除另有规定外,称取研成细粉的供试品或量取液体供试品,于25℃±2℃一定容量的溶剂中,每隔5分钟强力振摇30秒;观察30分钟内的溶解情况,如无目视可见的溶质颗粒或液滴时,即视为完全溶解。
9
试验温度
25.0 ± 0.5 °C
试验温度
未规定,可参考EP
试验温度
25℃±2℃