| 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
|
|
Crystallinity
|
meets the requirements.
|
Complies
|
|
Loss on drying
|
≤2.0%
|
0.19%
|
|
Heavy metals
|
≤10 ppm
|
<10ppm
|
|
Water
|
≤1.0%
|
0.1%
|
|
Sulphated ash
|
≤0.5%, determined on 1.0 g.
|
0.009%
|
|
Related substances
|
Unspecified impurities: for each impurity
|
≤0.10%
|
<0.10%
|
|
Total Impurity
|
≤0.5%
|
0.18%
|
|
Purity
|
≥99.0%
|
99.7%
|
|
Assay
|
99.0%~101.0% (anhydrous substance).
|
99.8%
|
|
Microbiological Analysis
|
|
Total plate count
|
≤1000cfu/g
|
Complies
|
|
Yeast and Moulds
|
≤100cfu/g
|
Complies
|
|
E. Coli.
|
Absent
|
Negative
|
|
Salmonella
|
Absent
|
Negative
|
|
S.aureus
|
Absent
|
Negative
|
|
Storage
|
Preserve in well-closed, light-resistant and airtight containers.
|
Complies
|
China
