Ropivacaine Hydrocloride Ropivacaine 132112-35-7
Cas: 132112-35-7
Standard: ≥99.5%, USP40
Appearance: White or off white crystalline powder
Usage: Anesthetic(local)
Package: 1kg/10kg/25kg
Ropivacaine HCLNaropin® Injection contains ropivacaine HCl, which is a member of the amino amide class of local anesthetics. Naropin Injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and Water for Injection. Sodium hydroxide and/or hydrochloric acid may be used for pH adjustment. It is administered. parenterally. Ropivacaine HCl is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide. hydrochloride monohydrate. The drug substance is a white crystalline powder, with a molecular
Product |
Ropivacaine HCL |
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batch No. |
18051606 |
Mfg. date |
2018-08-16 |
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Test Date |
2018-05-17 |
Retest. date |
2020-08-15 |
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Tests |
Results
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Specifications
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Description |
Complies |
White,crystalline powder |
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Solubility |
Complies |
Soluble in water |
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Identification |
Complies |
A: By IR, To match with working standard |
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Complies |
B: Test for chlorides. Reponds to the test for Chlorides. |
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Special test |
0.007 |
the absorbance at 405 nm is not more than 0.030 |
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0.006 |
the absorbance at 436 nm is not more than 0.025 |
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Complies |
Should be clear |
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5.20 |
pH:4.5-6.0 |
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5.61% |
Water:5.0%~6.0% |
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Clarity |
Complies |
Meets the requirements |
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Specific rotation |
-249° |
-210°~ -255° |
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Heavy metal |
<0.001% |
≤ 0.001% |
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Limit of ropivacaine related compound A 杂质A的限度 |
Complies 符合要求 |
≤10ppm |
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Related compounds 有关物质 |
Bupivacaine 布比卡因 |
0.018% |
≤0.2% |
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Any other individual impurity 其他单个杂质 |
<0.1% |
≤0.1% |
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Total impurities 总杂质量 |
0.03% |
≤0.5% |
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Enantiomeric purity |
0.19% |
≤0.5% |
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Residual Solvents |
N.D 0.06% N.D |
Ethanol ≤0.5% Acetone≤0.5% 4-Methyl-2-pentanone≤0.5% |
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Assay |
99.46% |
98.5~101.0% |
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Conclusion: Conforms to USP39 |
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The Quality Control Responsible:
Ropivacaine HCLNaropin® Injection contains ropivacaine HCl, which is a member of the amino amide class of local anesthetics. Naropin Injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and Water for Injection. Sodium hydroxide and/or hydrochloric acid may be used for pH adjustment. It is administered. parenterally. Ropivacaine HCl is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide. hydrochloride monohydrate. The drug substance is a white crystalline powder, with a molecular
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