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Model No.: 85650-52-8
| Items | Standard | Result |
| Appearance | White or off-white powder | Complies |
| Identification | The IR absorption spectrum is accordant with the spectrum obtained with CRS | Complies |
| Solubility | , Practically insoluble in water,freely soluble in anhydrous ethanol | Complies |
| specific rotation | -0.10°~+0.10° (anhydrous substance) | +0.001° |
| Water | ≤3.5% | 2.8% |
| Sulfated ash | ≤0.10% | 0.04% |
| granularity | 80%<75 m | 39.28 m |
| Residual solvents | Ethanol ≤5000ppm | 130ppm |
| Impurity | Impurity A A≤0.10% | ND |
| Impurity B B≤0.10% | ND | |
| Impurity C C≤0.10% | ND | |
| Impurity D D≤0.10% | ND | |
| Impurity E E≤0.10% | ND | |
| Impurity F F≤0.10% | ND | |
| Individual impurity ≤0.10% | ND | |
| Total impurities ≤0.20% | ND | |
| Microbial limit test | aerobic bacteria≤1000CFU/g | <10CFU/g |
| fungus≤1000CFU/g | <10CFU/g | |
| Absence of escherichia coli | ND | |
| Assay | 99.0~101.0%(anhydrous substance) | 100.0% |
| Conclusion | Complies to EP7.0 | |
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