| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Non-Customized |
|
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| Items | Requirements | Result |
| Appearance | White or almost white crystalline powder. | White crystalline powder |
| Solubility | Practically insoluble in water, freely soluble in ethano l(96 percent) | Conformed |
| Identification | The infrared spectrum should be conformed with the fusidic acid CRS, the residue does not give reaction of sodium. | Conformed |
| Related substances | Impurity M≤1.0% | 0.10% |
| Impurity G≤0.7% | None | |
| Impurity L≤0.5% | 0.06% | |
| Impurity B≤0.4% | None | |
| Impurity A≤0.3% | None | |
| Impurity H≤0.1% | 0.05% | |
| Impurity C≤0.2% | None | |
| Impurity D≤0.2% | None | |
| Impurity F≤0.2% | None | |
| Impurity I≤0.2% | None | |
| Impurity K≤0.2% | 0.10% | |
| Impurity N≤0.2% | None | |
| Unspecificated impurity≤0.1% | 0.07% | |
| Total impurities≤2.0% | 0.38% | |
| Water | 1.4%~2.0% | 1.89% |
| Sulfated ash | ≤0.2% | 0.01% |
| Assay (anhydrous substance) | 97.5%~101.0% | 99.62% |
| Residual solvents | Ethano l≤5000ppm | Conformed |
| Methano l≤3000ppm | Conformed | |
| Ethylacetat e≤5000ppm | Conformed | |
| N-hexan e≤290ppm | Conformed | |
| Conclusion | The product conforms to standard of EP9.0 | |
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