各国药典(EP、USP、CP)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USP和ChP2020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 | weigh weight 区别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℃ |
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