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Product 產(chǎn)品名稱: |
Ropivacaine MESYLATE 甲磺酸羅哌卡因 |
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batch No. 批號: |
23070301 |
Mfg. date 生產(chǎn)日期 |
2023.07.03 |
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Test Date 批準日期: |
2023.07.05 |
Exp. date 有效期至 |
2025.07.02 |
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Tests 項目 |
Results 結(jié)果 |
Specifications 標準 |
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Appearance 性狀 |
Complies 符合規(guī)定 |
White or off white crystalline powder 白色或類白色結(jié)晶性粉末 |
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Identification 鑒別 |
Complies 符合規(guī)定 |
(1):The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. 供試品主峰的保留時間應與對照品一致 |
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Complies 符合規(guī)定 |
(2): By IR, To match with working standard 紅外吸收圖譜應與對照品一致 |
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Colour 顏色 |
Complies 符合規(guī)定 |
Should be to match with the standard 應符合規(guī)定 |
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Clarity 澄清度 |
Complies 符合規(guī)定 |
Should be to match with the standard 應符合規(guī)定 |
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Specific rotation比旋度 |
-7.29° |
-6°~ -8° |
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Melting point熔點 |
153.5~154.5℃ |
150~155℃ |
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pH酸度 |
4.50 |
4.0 ~ 7.0 |
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Dextrotation右旋體含量 |
Complies |
£1.0% |
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Relative Substance 有關(guān)物質(zhì) |
0.10% |
£1.0% |
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2，6－dimethylaniline 2,6-二甲基苯胺 |
＜0.01% |
£0.01% |
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Loss on drying 干燥失重 |
0.14% |
£0.5% |
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Residue on ignition 熾灼殘渣 |
0.03% |
£0.1% |
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Heavy metal 重金屬 |
＜10 ppm |
£ 10 ppm |
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Assay 含量（HPLC） |
99.90% |
≥99.0% |
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Conclusion 結(jié)論 ： Conforms to Enterprise Standard 本品符合企業(yè)標準 |
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