Appearance
|
White to off-white crystalline powder
|
Conforms
|
Solubiltity
|
very soluble in acetronitrile, freely soluble in methanol, in
acetone, in alcohol, and in tetrahydrofuran
|
Conforms
|
Identification
|
IR
HPLC
|
Conform with standard IR
Conforms
|
Water
|
NMT 0.3%
|
0.1%
|
Residue on ignition
|
NMT 0.1%
|
Conforms
|
Heavy metals
|
NMT 0.001%
|
<10ppm
|
Related substances
Related Compound B
Related Compound C
Related Compound D
Related Compound E
Individual unspecified impurity
Total unspecified impurity
Total impurities
|
NMT 0.2%
NMT 0.2%
NMT 0.1%
NMT 0.1%
NMT 0.1%
NMT 0.2%
NMT 0.5%
|
0.07%
0.07%
0.06%
0.05%
0.06%
0.1%
0.5%
|
Residual solvents
Dichloromethane
Chloroform
Ethanol
Cyclohexane
Ethylacetate
|
NMT 0.06%
NMT 0.006%
NMT 0.5%
NMT 0.08%
NMT 0.5%
|
ND
ND
0.07%
0.03%
0.1%
|
Assay (on dry basis)
|
98.0%~102.0%
|
99.5%
|