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Product 產(chǎn)品名稱 |
PRILOCAINE base 丙胺卡因 |
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batch No. 批號 |
23043009 |
Mfg. date 生產(chǎn)日期 |
2023-04-30 |
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Approval Date 批準日期 |
2023-05-01 |
Exp. date 有效期至 |
2026-04-29 |
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Tests 項目 |
Results 結(jié)果 |
Specifications 標準 |
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Description性狀 |
White crystalline powder 類白色結(jié)晶性粉末 |
White or almost white crystalline powder白色或類白色結(jié)晶性粉末 |
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Solubility溶解度 |
Complies 符合規(guī)定 |
Very soluble in alcohol and in acetone; slightly soluble in water. 在乙醇和丙酮中極易溶，在水中微溶。 |
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Identification 鑒別 |
Complies 符合規(guī)定 |
By IR, to match with the working standard 紅外吸收圖譜應與對照品一致 |
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Melting point 熔點 |
36.9℃～38.5℃ |
36℃～39℃ |
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Water 水分 |
0.04% |
≤0.5% |
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Residue on ignition 熾灼殘渣 |
0.03% |
≤0.1% |
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Related compound A 有關(guān)物質(zhì)A |
Complies 符合規(guī)定 |
≤0.01% |
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Related compounds 有關(guān)物質(zhì) |
0.05% |
not more than 0.2% of any individual impurity 任一單個雜質(zhì)不得過0.2% |
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Complies 符合規(guī)定 |
not more than one impurity exceeds 0.1% 超過0.1%的雜貨不得過一個 |
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0.15% |
not more than 0.5% of total impurities 總雜質(zhì)和不得過0.5% |
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Residual solvents 溶劑殘留 |
Not detected 未檢出 |
Dichloromethane Not more than0.06% 二氯甲烷≤0.06% |
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Not detected 未檢出 |
Ethanol Not more than0.5% 乙醇≤0.5% |
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0.03% |
Isopropyl ether Not more than0.5% 異丙醚≤0.5% |
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Assay 含量 |
99.27% |
≥99.0% （on the anhydrous basis以干品計） |
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Conclusion ： Conforms to USP39 結(jié)論 ： 符合USP39標準 |
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