| Item |
Standard |
Testergebnisse |
| Identifikation |
A.H-NMR:Comply with the structure |
Entspricht |
|
B.LC-MS:Comply with the structure |
Entspricht |
|
C.The IR spectrum of sample should be identical with that of reference standard; |
Entspricht |
|
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. |
Entspricht |
| Crystallinity |
entspricht den Anforderungen. |
Entspricht |
| Trocknungsverlust |
≤2,0 % |
0.19% |
| Schwermetalle |
≤10 ppm |
<10ppm |
| Wasser |
≤1,0 % |
0.1% |
| Sulfatasche |
≤0,5 %, determined on 1.0 g. |
0.009% |
| Verwandte Substanzen |
Unspecified impurities: for each impurity |
<0.10% |
|
Total Impurity |
0.18% |
| Reinheit |
≥99,0 % |
99.7% |
| Probe |
99.0%~101.0% (anhydrous substance). |
99.8% |
| Microbiological Analysis |
|
|
| Total plate count |
≤1000cfu/g |
Entspricht |
| Yeast and Moulds |
≤100cfu/g |
Entspricht |
| E. Coli. |
Absent |
Negative |
| Salmonella |
Absent |
Negative |
| S.aureus |
Absent |
Negative |
| Lagerung |
Preserve in well-closed, light-resistant and airtight containers. |
Entspricht |
