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Product 產品名稱 |
Ropivacaine HCL 鹽酸羅哌卡因 |
Quantity 數量 |
25KG |
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batch No. 批號 |
23092003 |
Mfg. date 生產日期 |
2023.09.20 |
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Test Date 批準日期 |
2023.09.28 |
Retest date 復驗期 |
2026.09.19 |
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Tests項目 |
Results 結果 |
Specifications 標準 |
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Description性狀 |
Complies 符合要求 |
White, crystalline powder 白色結晶性粉末 |
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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 鑒別 |
Complies 符合要求 |
A: By IR, To match with working standard A: IR圖譜應與對照品一致 |
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Complies 符合要求 |
B: Test for chlorides. Reponds to the test for Chlorides. B: 應顯氯化物鑒別反應 |
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Color 顏色 |
0.007 |
NMT 0.030 at 405nm, and m. 在405nm處吸光度不得過0.030 |
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0.001 |
NMT 0.025 at 436nm 在436nm處吸光度不得過0.025 |
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Clarity 澄清度 |
Complies 符合要求 |
Meets the requirements 應符合要求 |
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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 重金屬 |
﹤0.001% |
≤ 0.001% |
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Organic impurity 有關物質 |
Bupivacaine 布比卡因 |
N.D. |
≤ 0.2% |
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Any other individual impurity 其他單個雜質 |
0.0061% |
≤ 0.1% |
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Total impurities 總雜質 |
0.018% |
≤ 0.5% |
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Ropivacaine Related compound A 羅哌卡因有關物質A |
Not detect 未檢出 |
≤ 10ppm |
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Enantiomeric purity 對映體純度 |
Not detect 未檢出 |
≤ 0.5% |
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Residual Solvents 溶劑殘留 |
Not detect 未檢出 |
Ethyl alcohol 乙醇≤ 0.5% |
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0.09% |
Acetone丙酮≤ 0.5% |
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Not detect 未檢出 |
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 結論 ： Conforms to USP41 本品符合USP41標準 |
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