Product Name

Rocuronium Bromide

Batch No

BJZSRB120929

Date Of Producing

2012.09.29

Package

910g

Date Of Expire

2014.09.28

Cas No

119302-91-9

Reference Standard

Ep7.0

items

specification

Results

Appearance

Almost white or pale yellow powder

Complied

Solubility

Freely soluble in water and anhydrous ethanol

Complied

Identification

a) IR Spectrum (KBr)

b) Bromide Test     

Must comply with Ep6.0

Must comply with Ep6.0

Complied

Complied

Test

Appearance Of Solution

Must comply with Ep6.0

Complied

Specific Optical Rotation

Between +28.5°～+32.0°

+30.3°

pH

Between 8.9～9.5

9.2

Heavy Metals

Not more than 10ppm

Complied

Water Content

Not more than 4.0%

3.5%

Sulphated ash

Not more than 0.1%

0.07%

chlorides

Not more than 0.1%

0.07%

Total impurities

Not more than 1.5%

Complied

Unknown impurities(each)

Not more than 0.1%

Complied

Impurity A

Not more than 0.2%

0.096%

Impurity B

Not more than 0.3%

Nil

Impurity C

Not more than 0.3%

0.05%

Impurity D

Not more than 0.1%

Nil

Impurity E

Not more than 0.1%

Nil

Impurity F

Not more than 0.1%

Nil

Impurity G

Not more than 0.1%

Nil

Impurity H

Not more than 0.1%

0.05%

Residual Solvents

Acetonitrile

Not more than 0.5%

Nil

Dichloromethane

Not more than 0.06%

0.02%

Ether

Not more than 5000

900

Methanol

Not more than 3000

1900

Assay of Rocuronium Bromide On Anhydrous Basis

Not less than 99.0% and not more than 101.0%

99.5%

Conclusion：The Sample Complies With Specification Of Ep7.0