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检验报告单
Certificate of Analysis
产品名称 Product Name |
酒石酸肾上腺素 Epinephrine Bitartrate |
CAS 编码 CAS No. |
51-42-3 |
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分 子 式 Molecular Formula |
C9H13NO3·C4H6O6 |
数 量 Quantity |
5kg |
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批 号 Batch No. |
20190301 |
生产日期 Date of Production |
2019.03.01 |
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检验依据 |
USP38 |
检验日期 Durability Date |
2019.03.12 |
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有效日期 |
2021.03.01 |
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检验项目 Inspection Item |
检验标准 Requirements |
检验结果 Test Results |
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外 观 Appearance |
白色或灰白色的结晶性粉末 White or Grey crystalline powder |
符合规定 Complies |
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溶解性 solubility |
Freely soluble in water; slightly soluble in alcohol;practically insoluble in chloroform and in ether |
符合规定 Complies |
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鉴 别 Identification |
A:比旋度 [ α]D 20 Specific Rotation -50~-53.5° |
-51.2° |
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B:肾上腺素下测试 test under epinephrine |
符合规定Complies |
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熔 点Melting Point |
147~152°C |
147.2-147.6° |
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重酒石酸去甲肾上腺素≤% Limit of norepinephrine bitartrate |
≤4.0% |
1.1% |
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肾上腺酮 Limit of adrenalone |
≤0.2% |
符合规定 Complies |
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水 份 Lose on drying |
≤0.5% |
0.28% |
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残留溶剂≤ppm Residual So Vent |
2483ppm |
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残 渣≤% Residue On Ignition |
Negligible, from 100mg. |
符合规定 Complies |
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含量分析 (干基) Assay( Dried) |
97.0~102.0% |
99.8% |
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结 论Conclusion 符合标准规定Meets the Requirements |