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Ropivacaine 84057-95-4 Ropivacaine 84057-95-4

Ropivacaine 84057-95-4
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Basic information of  Ropivacaine :

Name

Ropivacaine

Alias

ROPIVACAINE MESYLATER; RopivacaineHcl/MesylateBase;ROPACARAINEHCL;(S)-N-(2,6-Dimethylphenyl)-1-pKIpyl-2-piperidinecarboxamide;Naropin;2-Piperidinecarboxamide, N-(2,6-dimethylphenyl)-1-propyl-, (2S)-;Naropine;(2S)-1-Propyl-2-(2,6-dimethylphenyl)carbamoylpiperidine

CAS NO.

84057-95-4

Molecular Formula

C17H26N2O

Molecular Weight

274.4

Brief Introduction

Ropivacaine isthe aminoamide local anesthetics. For surgical, labor and postoperative analgesia.


Use of  Ropivacaine: 

Ropivacaine is the first pure L-segment long-acting amide local anesthetic. Like other local anesthetics, it blocks reversible blockages of sodium ions flowing into the nerve fiber membranes and impairs impulse conduction along the nerve fibers. With the dual effect of analgesia, large doses can produce surgical anesthesia, and at low doses, sensory block (analgesia) is only accompanied by limited non-progressive motor block. The addition of epinephrine did not change the block strength and duration of ropivacaine.

COA of Ropivacaine :

Test Items

Standard

Test Results

Character

White, crystalline powder, Soluble in water

Complies

Identification

a. Infrared Absorption

b. A solution (1 in 100) responds to the test for chloride.

Complies

Complies

Color

The absorbance at 405nm is not more than 0.030.

The absorbance at 436nm is not more than 0.025.

Complies

Clarity

Meets the requirement.

Complies

Acidity(PH)

4.5~6.0

4.8

Related Substances

Total impurity: Not more than0.5%

Single impurity: Less than0.1%

Bupivacaine: Not more than 0.2%

0.10%

0.03%

N.D.

Water

5.0%~6.0%

5.4%

Heavy metals

Not more than10ppm

Complies

2,6-Dimethylaniline

Not more than10ppm

N.D.

Enantiomeric Purity

Not more than0.5%

Complies

Residual Solvents

Acetone: Not more than0.5%

Ethanol: Not more than0.5%

4-methyl-2-pentanone: Not more than0.5%

Complies

Complies

Complies

Assay

98.5%~101.0%

99.42%

Bacterial endotoxins

Not more than 60,0 EU/g

Complies

Total aerobic microbial count

Not exceed 1000 CFU/g

Complies

Total combined yeasts/molds count

Not exceed 100 CFU/g

Complies

Salmonella sp

Absence in 10,0g

Complies

Escherichia coli

Absence in 1,0g

Complies

Pseudomonas aeruginosa

Absence in 1,0g

Complies

Staphylococcus aureus

Absence in 1,0g

Complies

Storage Conditions

storage temperature: between 15-30℃. Do not freeze. Store in a dry and well-ventilated location. Store in an air-tight container away from heat.



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MORE_DETAIL Ropivacaine 84057-95-4

Basic information of  Ropivacaine :

Name

Ropivacaine

Alias

ROPIVACAINE MESYLATER; RopivacaineHcl/MesylateBase;ROPACARAINEHCL;(S)-N-(2,6-Dimethylphenyl)-1-pKIpyl-2-piperidinecarboxamide;Naropin;2-Piperidinecarboxamide, N-(2,6-dimethylphenyl)-1-propyl-, (2S)-;Naropine;(2S)-1-Propyl-2-(2,6-dimethylphenyl)carbamoylpiperidine

CAS NO.

84057-95-4

Molecular Formula

C17H26N2O

Molecular Weight

274.4

Brief Introduction

Ropivacaine isthe aminoamide local anesthetics. For surgical, labor and postoperative analgesia.


Use of  Ropivacaine: 

Ropivacaine is the first pure L-segment long-acting amide local anesthetic. Like other local anesthetics, it blocks reversible blockages of sodium ions flowing into the nerve fiber membranes and impairs impulse conduction along the nerve fibers. With the dual effect of analgesia, large doses can produce surgical anesthesia, and at low doses, sensory block (analgesia) is only accompanied by limited non-progressive motor block. The addition of epinephrine did not change the block strength and duration of ropivacaine.

COA of Ropivacaine :

Test Items

Standard

Test Results

Character

White, crystalline powder, Soluble in water

Complies

Identification

a. Infrared Absorption

b. A solution (1 in 100) responds to the test for chloride.

Complies

Complies

Color

The absorbance at 405nm is not more than 0.030.

The absorbance at 436nm is not more than 0.025.

Complies

Clarity

Meets the requirement.

Complies

Acidity(PH)

4.5~6.0

4.8

Related Substances

Total impurity: Not more than0.5%

Single impurity: Less than0.1%

Bupivacaine: Not more than 0.2%

0.10%

0.03%

N.D.

Water

5.0%~6.0%

5.4%

Heavy metals

Not more than10ppm

Complies

2,6-Dimethylaniline

Not more than10ppm

N.D.

Enantiomeric Purity

Not more than0.5%

Complies

Residual Solvents

Acetone: Not more than0.5%

Ethanol: Not more than0.5%

4-methyl-2-pentanone: Not more than0.5%

Complies

Complies

Complies

Assay

98.5%~101.0%

99.42%

Bacterial endotoxins

Not more than 60,0 EU/g

Complies

Total aerobic microbial count

Not exceed 1000 CFU/g

Complies

Total combined yeasts/molds count

Not exceed 100 CFU/g

Complies

Salmonella sp

Absence in 10,0g

Complies

Escherichia coli

Absence in 1,0g

Complies

Pseudomonas aeruginosa

Absence in 1,0g

Complies

Staphylococcus aureus

Absence in 1,0g

Complies

Storage Conditions

storage temperature: between 15-30℃. Do not freeze. Store in a dry and well-ventilated location. Store in an air-tight container away from heat.


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