盐酸罗哌卡因132112-35-7
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Product 产品名称 |
Ropivacaine HCL 盐酸罗哌卡因 |
Quantity 数量 |
25KG |
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batch No. 批号 |
23092003 |
Mfg. date 生产日期 |
2023.09.20 |
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Test Date 批准日期 |
2023.09.28 |
Retest date 复验期 |
2026.09.19 |
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Tests项目 |
Results 结果 |
Specifications 标准 |
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Description性状 |
Complies 符合要求 |
White, crystalline powder 白色结晶性粉末 |
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Solubility溶解度 |
Complies 符合要求 |
Soluble in water 在水中溶解 |
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Identification 鉴别 |
Complies 符合要求 |
A: By IR, To match with working standard A: IR图谱应与对照品一致 |
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Complies 符合要求 |
B: Test for chlorides. Reponds to the test for Chlorides. B: 应显氯化物鉴别反应 |
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Color 颜色 |
0.007 |
NMT 0.030 at 405nm, and m. 在405nm处吸光度不得过0.030 |
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0.001 |
NMT 0.025 at 436nm 在436nm处吸光度不得过0.025 |
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Clarity 澄清度 |
Complies 符合要求 |
Meets the requirements 应符合要求 |
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pH酸度 |
5.18 |
4.5~6.0 |
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Water 水分 |
5.56% |
5.0%~6.0% |
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Heavy metal 重金属 |
﹤0.001% |
≤ 0.001% |
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Organic impurity 有关物质 |
Bupivacaine 布比卡因 |
N.D. |
≤ 0.2% |
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Any other individual impurity 其他单个杂质 |
0.0061% |
≤ 0.1% |
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Total impurities 总杂质 |
0.018% |
≤ 0.5% |
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Ropivacaine Related compound A 罗哌卡因有关物质A |
Not detect 未检出 |
≤ 10ppm |
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Enantiomeric purity 对映体纯度 |
Not detect 未检出 |
≤ 0.5% |
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Residual Solvents 溶剂残留 |
Not detect 未检出 |
Ethyl alcohol 乙醇≤ 0.5% |
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0.09% |
Acetone丙酮≤ 0.5% |
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Not detect 未检出 |
4-methyl-2-pentone 4-甲基-2-戊酮≤ 0.5% |
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Assay 含量 |
99.32% |
98.5~101.0% |
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Conclusion 结论 ： Conforms to USP41 本品符合USP41标准 |
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