Appearance White or almost white powder
Identification (1),(2),(3) must complies with the EP 7.0
Melting point 200℃~ 204℃
Specific optical rotation +58.0°~ +62.0°
Impurity A Not more than 1.0%
Impurity C Not more than 0.1%
Any other impurity
B,D,E,F,G,H,I Not more than 0.1%
The unknown impurity Not more than 0.1%
Total impurity Not more than 1.5%
Sulfate Not more than 0.05%
Chloride Not more than 0.02%
Sulfated ash Not more than 0.1%
Loss on drying Not more than 1.0%
metals Not more than 10ppm
Purity(HPLC) Not less than 99.0%
Assay ( on dried basis) 99.0% ~ 101.0%