Edoxaban Edoxaban factory 912273-65-5
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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 |
Complies |
||
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. |
|||
Heavy metals |
≤10 ppm |
<10ppm |
|
Water |
≤1.0% |
0.10% |
|
Sulphated ash |
≤0.5%, determined on 1.0 g. |
0.01% |
|
Related substances |
Unspecified impurities: for each impurity |
≤0.10% |
<0.10% |
Total Impurity |
≤0.5% |
0.18% |
|
Purity |
≥99.0% |
99.70% |
|
Assay |
99.0%~101.0% (anhydrous substance). |
99.80% |
|
Storage |
Preserve in well-closed, light-resistant and airtight containers. |
Complies |
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