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%
|