Function: | Anti Androgen |
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Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Powder |
Volatile: | Not Volatile |
Standard: | Ep8 |
Samples: |
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Items | Standard | Results |
Characters | White or almost white crystalline powder | almost white crystalline powder |
Solubility | practically insoluble in water,very soluble in methylene chloride,freely soluble in acetone,soluble in methanol,sparingly soluble in anhydrous ethanol. | complies |
Identification | Firsrt identification:A(IR) Second identification:B(TLC),C,D,E |
complies |
Melting point | About 210ºC | 207.0~208.5ºC |
Specific optical rotation | +152°~+157° | +156.5° |
Related substance (by HPLC) | Impurity F(RRT about 0.5)<0.4% | N.D |
Impurity E(RRT about 0.27)<0.2% | 0.08% | |
Impurity B(RRT about 0.7)<0.15% | N.D | |
Impurity C(RRT about 1.5)<0.15% | N.D | |
Impurity G(RRT about 0.3)<0.15% | N.D | |
Uninspected impurities<0.10% | 0.08% | |
Total impurities<0.5% | 0.28% | |
Loss on drying | Not more than 0.5% | 0.12% |
Sulphated ash | Not more than 0.1% | 0.04% |
Assay(UV) | 97.0%~103.0% | 100.3% |
Particle size | 100%<20um | complies |
Conclusion:The product complies with the requirements of EP8. | ||
Storage:Preserve in tight containers,and store at controlled room temperature. |
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