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Ropivacaine

Ropivacaine

Quick Details ● ProName: Ropivacaine HCL ● CasNo: 132112-35-7 ● Molecular Formula: C17H26N2O.HCL ● Appearance: White or off white crystalline powder ● Application: Ropivacaine HCLNaropin Injection cont... ● DeliveryTime: 15days ● PackAge: 1kg/10kg/25kg/Drum ● Port: wuhan Shanghai ●...

Products Specifications:

Quick Details

● ProName: Ropivacaine HCL

● CasNo: 132112-35-7

● Molecular Formula: C17H26N2O.HCL

● Appearance: White or off white crystalline powder

● Application: Ropivacaine HCLNaropin Injection cont...

● DeliveryTime: 15days

● PackAge: 1kg/10kg/25kg/Drum

● Port: wuhan  Shanghai

● ProductionCapacity: 1 Metric Ton/Day

● Purity: 99%

● Storage: STORAGE CONDITION:COOL,DRY AND ROOM TE...

● Transportation: transportation by sea, air transportat...

● LimitNum: 1 Kilogram

● Moisture Content: 5.0%~6.0%

● Impurity: 98.5~101.0%

● Solubility: Soluble in water


Superiority
cas: 132112-35-7
standard: ≥99.5%, usp40
appearance: white or off white crystalline powder
usage: anesthetic(local)
package: 1kg/10kg/25kg


description:
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


COA:

product

ropivacaine hcl

batch no.

18051606

mfg. date

2018-08-16

test date

2018-05-17

retest. date

2020-08-15

tests

results

specifications

description

complies

white,crystalline powder

solubility

complies

soluble in water

identification

complies

a: by ir, to match with working standard

complies

b: test for chlorides. reponds to the test for chlorides.

special test

0.007

the absorbance at 405 nm is not more than 0.030

0.006

the absorbance at 436 nm is not more than 0.025

complies

should be clear

5.20

ph:4.5-6.0

5.61%

water:5.0%~6.0%

clarity

complies

meets the requirements

specific rotation

-249°

-210°~ -255°

heavy metal

<0.001%

≤ 0.001%

limit of ropivacaine related compound a

complies

≤10ppm

related compounds

bupivacaine

0.018%

≤0.2%

any other individual impurity

<0.1%

≤0.1%

total impurities

0.03%

≤0.5%

enantiomeric purity

0.19%

≤0.5%

residual solvents

n.d
 0.06%
n.d

ethanol ≤0.5%
acetone≤0.5%
4-methyl-2-pentanone≤0.5%

assay

99.46%

98.5~101.0%

conclusion:conforms to usp39


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