品名 (Name) | 熊去氧胆酸 | 英文名 | Ursodeoxycholic |
分子式 (Chemical formula) | C24H40O3 | CAS | 128-13-2 |
生产车间 (Workshop) | 生化车间 (Biochemical Workshop) |
项目 Testing Items | 标准规定 Specification |
鉴别 (Identification) | IR: 红外图谱与对照品一致 The infrared absorption spectrum of sample is completely in conformity with the spectrum of ursodeoxychloric acid CRS. |
TLC: 薄层斑点与对照品一致 The principle spot in the chromatogram obtained with test solution is similar in position, color and size to the principal spot in the chromatogram obtained with reference solution. |
比色法鉴别，溶液显蓝绿色 Colorimetric Detection: The suspension obtained in greenish-blue. |
性状 (Appearance) | 白色或类白色粉末 White or Off-white powder |
含量 (Content) | ≥98.5% |
溶解度 (Solubility) | 不溶于水，易溶于乙醇 Practically insoluble in water, freely soluble in ethanol (96%), slightly soluble in acetone, practically insoluble in methylene chloride. |
熔点 (Melting Point) | 200℃~ 204℃ |
干燥失重 (Loss on Drying) | ≤1.0% |
旋光 (Optical Rotation) | +58.0°~ +62.0° |
重金属 (Heavy Metals) | ≤20PPM |
残渣 (Sulphated Ash) | ≤0.1% |
杂质 (Impurity) | 石胆酸(Lithocholic acid)≤0.1% |
相关物质 (Related Substance) | 鹅去氧胆酸(Chenodeoxycholic acid)≤1.0% |
任何未指明的单一杂质 (Any unspecified single impurity )≤0.1% |
总杂质 (Total impurities )≤1.5% |