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Assay: 99.30% by HPLC
Standard: Enterprise Standard
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|Product Name||Levobupivacaine hydrochloride|
|Batch .||15061201||Mfg. date||2019.01.08|
|Approval Date||2019.01.08||Date of Expiry||2021.01.07|
|Results Of Analysis Tests|
|Character||White or off-white crystalline powder, smell-less. Soluble in the ethanol freely, in the chloroform slightly, and soluble in the water or 0.01mol/L HCl||Complies|
|Identification||1) Separate out the yellow deposition 2) There is the max absorbance between 263nm to 271 nm wavelength.||Complies|
|Total impurity||Not more than 0.5%||0.17%|
|Optical isomers||Not more than 0.5%||N.D|
|Loss on drying||Not more than 1.0%||0.21%|
|Burnt residue||Not more than 0.1%||0.05%|
|Heavy metals||Not more than 20ppm||Complies|
|Ferric salt||Not more than 0.001%||Complies|
|Assay||98.5%( calculated on the anhydrous basis.)||99.30%|
|Conclusion||Be Conform With Enterprise Standard|
Levobupivacaine (rINN) is a local anaesthetic drug belonging to the amino amide group. It is the S-enantiomer of bupivacaine.
The hydrochloride salt of levobupivacaine, an amide derivative with anesthetic property. Levobupivacaine reversibly binds voltage-gated sodium channels to modulate ionic flux and prevent the initiation and transmission of nerve impulses (stabilizing neuronal membrane), thereby resulting in analgesia and anesthesia. In comparison with racemic bupivacaine, levobupivacaine is associated with less vasodilation and has a longer duration of action.