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檢驗報告單
Certificate of Analysis
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產(chǎn)品名稱 Product Name |
酒石酸腎上腺素 Epinephrine Bitartrate |
CAS 編碼 CAS No. |
51-42-3 |
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分 子 式 Molecular Formula |
C9H13NO3·C4H6O6 |
數(shù) 量 Quantity |
5kg |
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批 號 Batch No. |
20190301 |
生產(chǎn)日期 Date of Production |
2019.03.01 |
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檢驗依據(jù) |
USP38 |
檢驗日期 Durability Date |
2019.03.12 |
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有效日期 |
2021.03.01 |
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檢驗項目 Inspection Item |
檢驗標準 Requirements |
檢驗結果 Test Results |
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外 觀 Appearance |
白色或灰白色的結晶性粉末 White or Grey crystalline powder |
符合規(guī)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 |
符合規(guī)定 Complies |
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鑒 別 Identification |
A：比旋度 [ α]D 20 Specific Rotation -50～-53.5° |
-51.2° |
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B:腎上腺素下測試 test under epinephrine |
符合規(guī)定Complies |
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熔 點Melting Point |
147～152°C |
147.2-147.6° |
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重酒石酸去甲腎上腺素≤% Limit of norepinephrine bitartrate |
≤4.0% |
1.1% |
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腎上腺酮 Limit of adrenalone |
≤0.2% |
符合規(guī)定 Complies |
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水 份 Lose on drying |
≤0.5% |
0.28% |
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殘留溶劑≤ppm Residual So Vent |
2483ppm |
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殘 渣≤% Residue On Ignition |
Negligible, from 100mg. |
符合規(guī)定 Complies |
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含量分析 (干基) Assay( Dried) |
97.0～102.0% |
99.8% |
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結 論Conclusion 符合標準規(guī)定Meets the Requirements |
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