|
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-MSThe 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% |
|
Residue on ignition |
≤0.1% |
0.03% |
|
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 & 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 |
