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品 名 Product Name |
醋酸潑尼松龍 Prednisolone Acetate |
來源地 Source |
車間2 |
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批 號 Batch Number |
20190406 |
生產(chǎn)日期 Manufacture Date |
2019.04.06 |
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重 量 Quantity |
2KG |
有效期至 Expiry Date |
2021.04.05 |
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檢測標(biāo)準(zhǔn) Standards |
USP38 |
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檢驗項目/Test Items |
標(biāo)準(zhǔn)/ Specifications |
結(jié)果/Results |
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外觀 Appearance |
白色或類白色結(jié)晶性粉末 White or almost white, crystalline powder |
符合 Conform |
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溶解度 Solubility |
本品在無水乙醇和三氯甲烷中微溶，在水中幾乎不溶。Practically insoluble in water, slightly soluble in ethanol(96% percent)and in methylene chloride. |
符合 |
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比旋度 Specific Optical Rotation |
+112º~ +119º |
+118.3º |
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鑒別(B) Identification |
Complies with the standard |
Complies |
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有關(guān)物質(zhì) Related substances |
任何雜質(zhì) ≤ 1.0 % Any impurity ≤ 1.0 % |
0.22% |
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總 雜≤ 2.0% Total impurities≤ 2.0% |
0.81% |
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殘留溶劑 Residual solvent |
甲醇≤0.3% Methanol≤0.3%
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Conform |
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干燥失重 Loss on drying |
≤1.0% |
0.07% |
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顆粒度 Particle size |
80%≤50um |
Conform |
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含量 Content |
含C23H30O6應(yīng)為97.0%~ 102.0%(以干品計) 97.0 percent to 103.0 percent (dried substance) |
99.38% |
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結(jié)論 Conclusion |
符合 USP38標(biāo)準(zhǔn) Be conform with USP38 |
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