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Introduction
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Specification
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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.
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Test |
Acceptance criteria |
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White or almost white, crystalline powder
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Solubility
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Freely soluble in ethanol, slightly soluble chloroform, soluble in water or Hydrochloride solution 0.01mol/L
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Specific optical rotation
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-11.0°~ -14.0° |
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Identification
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Identified
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pH
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4.5~6.0
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Clarity of solution
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Clear
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| Related substances
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Total impurities: not more than the area of the principal peak in the chromatograph obtained with reference solution (1.0%).
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Dextroisomer
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Not more than the area of the principal peak in the chromatograph obtained with reference solution (0.5%).
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Loss on drying
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Not more than 1.0%
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Sulfated ash
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Not more than 0.1%
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Heavy metals
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Not more than 20 ppm
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Ferric salt
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Not more than 0.001%
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