|
Item
|
Standard
|
Test Results
|
|
Identification
|
A.H-NMR:Comply with the structure
|
Complies
|
|
B.LC-MS:Comply with the structure
|
Complies
|
|
C.The IR spectrum of sample should be identical with that of reference standard;
|
Complies
|
|
D.HPLC-ESI-MS
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
|
Complies
|
|
Loss on drying
|
¡Ü0.5%
|
0.11%
|
|
Heavy metals
|
¡Ü10 ppm
|
<10ppm
|
|
Sulphated ash
|
¡Ü0.2%, determined on 1.0 g.
|
0.009%
|
|
Related substances
|
Unspecified impurities: for each impurity
|
¡Ü0.10%
|
<0.10%
|
|
Total Impurity
|
¡Ü1.0%
|
0.18%
|
|
Purity
|
¡Ý99.0%
|
99.82%
|
|
Assay
|
99.0%~101.0% (anhydrous substance).
|
99.9%
|
