CAS No:6990-06-3
Shelf life:2 years
The detailed specifications are as below:
| Items | Standard |
| Appearance | White or almost white crystalline powder |
| Solubility | Practically insoluble in water,freely Conformed Soluble in ethanol(96 percent) |
| Identification | The infrared spectrum should be conformed with Conformed the fusidic acid CRS |
| The residue dose not give reaction of sodium | |
| Water | 1.4%- 2.0% |
| Content( anhydrous substance) | 97.5%- 101.0% |
| Sulfated ash | ≤0.2% |
| Related Impurity by HPLC | Impurity M≤1.0% |
| Impurity G≤0.7% | |
| Impurity L≤0.5% | |
| Impurity B≤0.4% | |
| lmpurityA≤0.3% | |
| Impurity H≤0.1% | |
| Impurity C≤0.2% | |
| Impurity D≤0.2% | |
| Impurity F≤0.2% | |
| Impurity l≤0.2% | |
| Impurity K≤0.2% | |
| Impurity N≤0.2% | |
| Main unspecified impurities≤0.1 % | |
| Total impurities≤2 .0% | |
| Particle diamite<20µm | > 90% |
| Particle diamite<30µm | 100% |
| Residual solvents | Ethanol≤5000ppm |
| Methanol≤3000ppm | |
| Ethyl acetate≤5000ppm | |
| N-Hexan≤290ppm |