Function: | Antibiotic and Antimicrobial Agents |
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Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Solid |
Volatile: | Not Volatile |
Shelf Life: | 2 Years |
Samples: |
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Product Name | Fusidic Acid | CAS | 6990-06-3 | |
According to | EP10.4 | |||
Items | Standard | Results | ||
Appearance | White or almost white crystalline powder | white crystalline powder | ||
Solubility | Practically insoluble in water,freely Conformed Soluble in ethanol(96 percent) | Complies | ||
Identification | The infrared spectrum should be conformed with Conformed the fusidic acid CRS | Complies | ||
The residue dose not give reaction of sodium | Complies | |||
Water | 1.4%- 2.0% | 1.45% | ||
Content( anhydrous substance) | 97.5%- 101.0% | 99.8% | ||
Sulfated ash | ≤0.2% | 0.07% | ||
Related Impurity by HPLC |
Impurity M≤1.0% | 0.13% | ||
Impurity G≤0.7% | ND | |||
Impurity L≤0.5% | 0.02% | |||
Impurity B≤0.4% | ND | |||
lmpurityA≤0.3% | ND | |||
Impurity H≤0.1% | 0.02% | |||
Impurity C≤0.2% | ND | |||
Impurity D≤0.2% | ND | |||
Impurity F≤0.2% | ND | |||
Impurity l≤0.2% | ND | |||
Impurity K≤0.2% | 0.02% | |||
Impurity N≤0.2% | ND | |||
Main unspecified impurities≤0.1 % | ND | |||
Total impurities≤2 .0% | 0.18% | |||
Particle diamite<20µm | > 90% | 100% | ||
Particle diamite<30µm | 100% | 100% | ||
Residual solvents | Ethanol≤5000ppm | Complies | ||
Methanol≤3000ppm | Complies | |||
Ethyl acetate≤5000ppm | Complies | |||
N-Hexan≤290ppm | Complies |
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