USD $1.00-1.00 / Kilogram
USD $10.00-10.00 / Gram
USD $20.00-40.00 / Kilogram
USD $3.00-10.00 / Kilogram
USD $9.00-99.00 / Kilogram
USD $9.00-99.00 / Kilogram
USD $9.00-99.00 / Kilogram
USD $9.00-99.00 / Kilogram
USD $9.00-99.00 / Kilogram
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