Payment: T/T, L/C Product Origin: China Shipping Port: Beijing/Shanghai/Hangzhou Production capacity: 2000kg/month Order(MOQ): 25kg Lead Time: 3 Working Days Storage condition: Stored in cool, dry place, room temperature. Package material: drum Package size: 25kg/drum Safety information: Not dangerous goods| Item | Specification |
| Appearance | White or almost white powder |
| Solubility | Practically insoluble in water, freely soluble in ethanol (96%), slightly soluble in acetone, practically insoluble in methylene chloride |
| Melting point | 202-204℃ |
| Identification | Same IR spectrum as ursodeoxycholic acid CRS |
| The principal spot in the chromatogram obtained with the test solution (b) is similar in position, colour and size to the principle spot in the chromatogram obtained with reference solution (a). | |
| The suspension obtained is greenish-blue. | |
| Specific optical rotation | +58.0~+62.0° |
| Impurity C | Lithocholic acid ≤ 0.1% |
| Related substance (HPLC) | impurity A: chenodeoxycholic acid ≤ 1.0% |
| unspecified impurities ≤ 0.1% | |
| total ≤ 1.5% | |
| Heavy metals | ICH Q3D |
| Loss on drying | ≤ 1.0% |
| Sulphated ash | ≤ 0.1% |
| Assay | 99.0%~101% (Dried substance) |
| Residual solvents | Acetone ≤ 5000 ppm Ethyl acetate ≤ 5000 ppm Isopropanol ≤ 5000 ppm Ethanol ≤ 5000 ppm |
| Microbiological Tests | Total aerobic microbial count ≤ 10³CFU/g Total yeasts and moulds count ≤ 10²CFU/g Escherichia coli: Absent in 1 g Salmonella: Absent in 10 g |
| Additional properties | |
| Particle size distribution | 100% pass number 180 sieve (100% pass 80 mesh sieve) |