|
Item |
Standard |
Results |
Remark |
|
|
Appearance |
White or almost white crystalline powder |
Conforms |
|
|
|
Assay(on dried basis) |
98.5%-101.0% |
100.0% |
|
|
|
Specific optical rotation |
-121°~ -128° |
-124° |
|
|
|
Infrared Absorption |
Conforms to the spectrum obtained from Levamisole hydrochloride RS |
Conforms |
|
|
|
Identification by specific |
Conforms |
Conforms |
|
|
|
Identification of chlorides |
Positive |
Positive |
|
|
|
pH |
3.0~4.5 |
4.3 |
|
|
|
Related Substance(HPLC) |
Impurity A not more than 0.2% |
＜0.05% |
|
|
|
Impurity B not more than 0.2% |
＜0.05% |
|
||
|
Impurity C not more than 0.2% |
＜0.05% |
|
||
|
Impurity D not more than 0.2% |
0.1% |
|
||
|
Impurity E not more than 0.2% |
＜0.05% |
|
||
|
Any other impurity not more than 0.1% |
＜0.05% |
|
||
|
Total impurity not more than 0.3% |
0.1% |
|
||
|
Loss on drying |
≤0.5% |
0.10% |
|
|
|
Residue on Ignition |
≤0.1% |
0.012 |
|
|
|
Heavy metal |
≤20 ppm |
Conforms |
|
|
|
Conclusion |
The batch product complies with EP&BP |
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