Bupivacaine HCl

Bupivacaine HCl

Bupivacaine HCl CP

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Product Details

CAS No.

14252-80-3

Quality Specification

CP, USP

Certification

China GMP

Dossier

At request

Packaging

At request

Storage

As per USP CP


Item

Specification CP

Description

white crystalline powder, inodorous

Solubility

Easily soluble in   ethanol, soluble in water, slightly soluble in chloroform, almost insoluble   in diethyl ether

Identification

The wavelength of 263nm and 271nm has the maximum   absorption; its absorbance is 0.530.58 and   0.430.48 respectively

The infrared absorption spectrum of this   product should be consistent with reference spectrum (spectrum 324)

The aqueous solution of this product shows the   identification (1) of chloride

pH value

pH value should be 4.56.0

clarity and color of   solution

solution should be clear   and colorless

Related substance

 

adopt high performance   liquid chromatography, if there are impurity peaks in the sample solution   chromatogram, the total area of each impurity peak should not be greater than   the area of the peak of reference solution (1.0%)

loss on drying

should be 4.5%6.0%

residue on ignition

should not be greater   than 0.1%

copper salt

should not be deeper   than 0.0003%

Ferric salt

should not be deeper   than 0.001%

Solvent Residue

/

Bacterial Endotoxin

/

Microbial Limit

/

Assay

base on the calculation   of drying products, C18H28N2O·HCl should not be less than 98.5%


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