Rocuronium Bromide

Solubility

Freely soluble in water anhydrous ethanol

Complied

Identification

a) IR Spectrum (KBr)

b) Bromide Test     

Must comply with Ep5.4

Must comply with Ep5.4

Complied

Complied

Test

Appearance Of Solution

Must comply with Ep5.4

Complied

Specific Optical Rotation

Between +28.5°~+32.0°

+30.8°

pH

Between 8.9~9.5

9.1

Heavy Metals

Not more than 10ppm

Complied

Water Content

Not more than 4.0%

3.1%

Sulphated ash

Not more than 0.1%

0.06%

chlorides

Not more than 0.1%

0.07%

Total impurities

Not more than 1.5%

1.1%

unkonwn impurities(each)

Not more than 0.1%

0.05%

Impurity A

Not more than 0.2%

0.13%

Impurity B

Not more than 0.3%

Nil

Impurity C

Not more than 0.3%

0.23%

ImpurityD

Not more than 0.1%

Nil

Impurity E

Not more than 0.1%

Nil

Impurity F

Not more than 0.1%

0.03%

Impurity G

Not more than 0.1%

Nil

Impurity H

Not more than 0.1%

Nil

Residual Solvents

Acetonitrile

Not more than 410ppm

27ppm

Dichloromethane

Not more than 600ppm

19ppm

Assay of Rocuronium Bromide On Anhydrous Basis

Not less than 99.0% not more than 101.0%

99.4%

Conclusion:The Sample Complies With Specification Of  Ep5.