99% up Rocuronium Bromide 119302-91-9

Items                            Specifications                       Results

Appearance:       Almost white or light yellow powder,hygroscopicity       Complies 

Solubility:                     Freely soluble in water,                    Complies 

ethanol trichloromethane or Glacial acetic acid,almost insoluble in ether                                                 

Identification:            1)IR Spectrum(KBr),2)Bromide Test              Complies

Appearance of solution:            Comply with EP                      Complies

Specific rotation:                   +28.50~+32.00                                   +31.60

PH:                                 8.9~9.5                           9.0

Heavy metals:                     10ppm max.                         Complies

Water:                             3.5%max.                          1.8%

Residue on ignition:                 0.1%max.                          0.02%

Chlorides:                          0.1%max.                          0.03%

Total impurity:                       1.5%max.                          0.48%

Unknown impurity(each):             0.1%max.                          0.04%

Impurity A:                          0.2%max.                          0.09%

Impurity B:                          0.3%max.                          0.01%

Impurity C:                          0.3%max.                         0.09%

Impurity D:                          0.1%max.                         Nil

Impurity E:                          0.1%max.                         0.08%

Impurity F:                          0.1%max.                         0.02%

Impurity G:                          0.1%max.                         0.007%

Impurity H:                          0.1%max.                          Nil

Residual solvents:

Acetone:                           0.5%max.                           Nil

Dichloromethane:                   0.06%max.                          0.02%

Ether:                              0.5%max.                          0.02%

Methanol:                          0.3%max.                           Nil

Bacterial Endotoxin:  Endotoxin amount per 1mg product should be less than 0.5EU

Assay(on anhydrous base):          99.0~101.0%                        99.8%