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 |
Dihydroergotoxine mesylate
CAS 8067-24-1
Appearance : white powder
Purity : 99% min
Molecular formula: C20H29N3O5S
Molecular weight: 423.52600
Exact quality: 423.18300
PSA: 131.11000
LogP: 2.53850
Density: 1.34g/cm3
Boiling point: 899.5oC at 760 mmHg
Flash point: 497.8oC
Refractive index: 1.66
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