|
Appearance
|
White or almost white crystalline powder
|
|
Solubility
|
Practically insoluble in water,freely soluble in methanol and dichloromethane
|
|
IR
|
The IR spectrogram conforms to the characteristic peak of R.S.
|
|
HPLC
|
The retention time of the major pead in the chromatogram conforms to the characteristic peak of R.S.
|
|
Specific optical ratation
|
-38.5°～-41.5°
|
|
Water
|
5.0%～7.0%
|
|
Residue on ignition
|
Not more than 0.1%
|
|
Heavy Metals
|
Not more than10ppm
|
|
Impurity A
|
Not more than 0.15%
|
|
Impurity B
|
Not more than 0.15%
|
|
Impurity C
|
Not more than 0.15%
|
|
Impurity D
|
Not more than 0.1%
|
|
Single unknown impurity
|
Not more than 0.10%
|
|
Total impurities
|
Not more than 1.0%
|
|
n-Hexane
|
Not more than 290ppm
|
|
Ethyl acetate
|
Not more than 5000ppm
|
|
Acetone
|
Not more than 5000ppm
|
|
Dichloromethane
|
Not more than 600ppm
|
|
Methanol
|
Not more than 3000ppm
|
|
Assay (calcuaated on anhydrous basis)
|
98.5%～101.5%
|
>>Alphabetical order
