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品名 |
戊酸雌二醇 |
數量 |
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Product Name |
Estradiol valerate |
Batch Size |
10KG |
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生產日期 |
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批號 |
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Manufacturing Date |
2023.07.10 |
Batch No. |
2023.07.10 |
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有效期 |
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報告日期 |
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Expiry Date |
2025.07.10 |
Report Date |
2023.07.24 |
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檢驗依據 |
美國 藥典 43 版 |
包裝 |
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Reference Standard |
USP43 |
Packing |
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檢驗項目 |
質量標準 |
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檢驗結果 |
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TEST |
ACCEPTANCE CRITERIONS |
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RESULTS |
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正性反應 |
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鑒別 |
TLC |
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Positive |
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Identification |
UV spectrum |
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Positive |
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IR spectrum |
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Positive |
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性狀 |
白色結晶性粉末 |
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符合規定 |
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Characteristics |
White,crystalline powder |
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Conform |
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溶解度 |
Practically insoluble in water,soluble in castor oil,in |
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符合規定 |
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Solubility |
benzyl benzoate,and in dioxane, sparingly soluble in |
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Conform |
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sesane oil and in peanut oil. |
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熔點 |
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Melting point |
143 ~ 150℃ |
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144.8~ 148℃ |
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比旋度 |
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Specific roation |
﹢41°~﹢47° |
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﹢43.8° |
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水分 |
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Water |
≤0.1% |
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0.07% |
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含量 |
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Assay |
98.0~ 102.0％ |
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99.55% |
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雌二醇限量 |
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合格 |
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Limit of estradiol |
≤1.0% |
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pass |
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有機酸 |
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Free acid |
≤0.5% |
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0.22% |
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粒度 |
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合格 |
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Particle size |
100%≤20um |
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pass |
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結論 |
本批號符合 美國 藥典 43 版 |
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Conclusion |
This batch complies with USP43 |
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