China Obeticholic Acid 459789-99-2, Find details about China Obeticholic Acid, 459789-99-2 from Obeticholic Acid 459789-99-2
| Items | Standards | Results |
| Appearance | White or off-white solid powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Freely soluble in methanol,ethanol and THF,soluble in ethyl acetate, slightly soluble in water and acetone, insoluble in hexane and toluene | Complies |
| Water Content | ≤2.00% | 1.65% |
| Heavy Metals | ≤20ppm | Complies |
| Residue on Ignition | ≤0.20% | 0.07% |
| Residual Solvents | Methanol: ≤3000ppm | ND |
| Ethanol: ≤5000ppm | ND | |
| Butyl Acetate: ≤5000ppm | ND | |
| n-Heptane: ≤5000ppm | 2000ppm | |
| Related Substances | Impurity A: ≤0.30% | 0.16% |
| Impurity B: ≤0.15% | ND | |
| Any other impurities: ≤0.10% | ND | |
| Total impurities: ≤1.00% | 0.20% | |
| Assay | 98.0%~102.0% on anhydrous basis | 99.92% |
| Reference Standard | In-house Standard | |
| Conclusion | The product complied to In-house standard. | |
| Storage | Preserve in tight,light-resistant containers in a cool place | |