897-15-4 Dothiepin hydrochloride Dothiepin HCL
Item | Standard | Test Results | |
Identification |
A.H-NMR:Comply with the structure |
Complies |
|
B.LC-MS:Comply with the structure |
Complies |
||
C.The IR :Comply with the reference standard; |
Complies |
||
D.HPLC-ESI-MS |
Complies |
||
Crystallinity |
meets the requirements. |
Complies |
|
pH value |
3.0~4.5 |
4.3 |
|
Optical ratation |
-128 to -121 |
-123 |
|
Loss of Drying |
≤0.5% |
0.28% |
|
Sul. ash |
≤0.1% |
0.06% |
|
HPLC
|
Impurity A, B, C, D, E: for each impurity | ≤0.2% | Complies |
Unspecified impurities: for each impurity |
≤0.1% |
Complies |
|
Total Impurities | ≤0.3% | 0.15% | |
Assay |
98.5~101.0% |
100.1% |
|
Microbiological Analysis | |||
Total plant count |
<1000cfu/g |
Complies |
|
Yeast and Moulds | <100cfu/g | Complies | |
E. Coli.; Salmonella; S.aureus | Absent | Negative | |
Storage |
Preserve in well-closed, light-resistant and airtight containers. |
Complies |
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