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分析证明
Certificate of Analysis
品名Product Name |
十一酸雌二醇Estradiol undecanoate CAS:3571-53-7 |
||
生产日期 Manufacturing Date |
2024/05/12 |
批号 Batch No. |
202405001 |
有效期 Expiry Date |
2026/05/11 |
数量 Quantity |
500g |
检验依据 Reference Standard |
企标 Company standard |
包装 Packing |
100g/bag |
检验项目 TEST |
质量标准 ACCEPTANCE CRITERIONS |
检验结果RESULTS |
|
鉴别 Identification |
A:IR B:UV C:TLC B utraviolet absorption Absorptivitles at 281nm,calculated on the dried dasis,do not differ by more than 3.0% |
符合规定 Conform 符合规定 conform |
|
性状 Characteristics |
白色粉末 White crystalline powder |
符合规定 conform |
|
溶解度solubility |
不溶于水,溶于乙醇,丙酮、二氧六环、氯仿,微溶于植物油 ,practiclly insoluble in water,Soluble in alcohol,acetone,dioxane,chloroform;sparingly soluble in vegetable oils. |
符合规定 conform |
|
熔点Melting point |
About 110℃ |
109.8-110.6℃ |
|
比旋度 Specific rotation |
﹢51.0°~﹢56.0° |
﹢52.1° |
|
含量Assay |
97 .0~ 103.0% |
99.50% |
|
干燥失重 Loss on drying |
≤0.50% |
0.21% |
|
杂质总量 Total related substance |
≤2.0% |
0.38% |
|
单一杂质 Any individual impurity |
≤0.50% |
0.12% |
|
灼烧残渣 Residue ignition |
≤0.10% |
0.08% |
|
纯度Putity |
≥99.0% |
99.62% |
|
结论 Conclusion |
本品按企业标准检验,结果符合规定 Company standard,conform the stipulation. |