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Levobupivacaine Hydrochloride
  • Introduction
  • Specification

 

Levobupivacaine is the S-enantiomer of bupivacaine hydrochloride and is chemically described as (S)-1-butyl-2-piperidylformo-2', 6'-xylidide hydrochloride.

Levobupivacaine is a member of the amino amide class of local anaesthetics. It is indicated for surgical anesthesia and postoperative pain management.

 

Test

Acceptance criteria

Appearance

White or almost white, crystalline powder  

Solubility

Freely soluble in ethanol, slightly soluble chloroform, soluble in water or Hydrochloride solution 0.01mol/L

Specific optical rotation

-11.0°~ -14.0°

Identification

Identified 

pH

4.5~6.0

Clarity of solution

Clear 

Related substances

Total impurities: not more than the area of the principal peak in the chromatograph obtained with reference solution (1.0%).

Dextroisomer

 

Not more than the area of the principal peak in the chromatograph obtained with reference solution (0.5%).

Loss on drying

Not more than 1.0%

Sulfated ash

Not more than 0.1% 

Heavy metals

Not more than 20 ppm

Ferric salt

Not more than 0.001%

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