Test Item
|
Specification
|
Results
|
Appearance
|
White to off-white crystalline powder
|
White crystalline powder
|
Specific rotation
|
-30.7o ~ -32.6 o
|
-31.4 o
|
Identification:
|
IR: Spectrum of the sample corresponds to that of reference standard.
|
Conform
|
HPLC: The retention time of major peak of test solution should correspond to that of comparison solution.
|
Conform
|
Related substances
|
Impurity I NMT 0.1%
|
0.01%
|
Impurity II NMT 0.1%
|
ND
|
Impurity III NMT 0.1%
|
0.04%
|
Impurity IV NMT 0.1%
|
0.01%
|
Each of unspecified impurity NMT 0.1%
|
0.05%
|
Total impurities NMT 0.5%
|
0.1%
|
Related solvents
|
Acetone NMT 5000ppm
|
81ppm
|
Ethanol NMT 5000ppm
|
ND
|
Dichloromethane NMT 600ppm
|
ND
|
Ethyl acetate NMT 5000ppm
|
ND
|
n-Heptane NMT 5000ppm
|
ND
|
Toluene NMT 890ppm
|
ND
|
Water
|
NMT 0.5%
|
0.3%
|
Heavy metals
|
NMT 10ppm
|
Conform
|
Assay
|
98.0% ~ 101.5% (on anhydrous basis)
|
99.4%
|
Conclusion
|
The product conforms to the above specifications
|