| Appearance | White or almost white powder
|
| Solubility | Practically insoluble in water, freely soluble in ethanol (96 percent),slightly soluble in acetone, practically insoluble in methylene chloride
|
| Identification | Infrared absorption, TLC and chrominance test
|
| Melting point | About 202oC
|
| Specific optical rotation | [α ]D20; +58.0o~+62.0o
|
| Heavy metals | ≤ 20PPM
|
| Loss on drying | ≤ 1.0%
|
| Sulphated ash | ≤ 0.1%
|
| Residual solvents |
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| Acetone | ≤ 0.5%
|
| Methanol | ≤ 0.3%
|
| Secondary Butyl Alcohol | ≤ 0.5%
|
| Assay (titration) | 99.0%~101.0%(on the dried basis)
|
| Related substance(TLC) |
|
| Lithocholic acid | ≤ 0.1%
|
| Cholic acid | ≤ 0.5%
|
| Chenodeoxycholic Acid | ≤ 1.0%
|
| Others | ≤ 0.25%
|
| Standard | EP grade
|
| Content | 99.0~101.0%
|
| Capacity | 10MT/month
|
| Loading port | Shanghai
|
| Use | Ursodeoxycholic acid, Used as an anticholelithogenic. Epimer with Chenodiol with respect to the hydroxyl group at C7.
|
| Package | 25kg/drum or according to the customers’ demand
|
| Storage | Stored in the dry and ventilated inside storeroom, prevent direct sunlight, slightly pile and put down |
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