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Meclizine dihydrochloride
· Molecular Formula:C25H27ClN2.2(HCl)
· Molecular Weight:463.87
· CAS Registry Number:1104-22-9
Specification:
|
ITEM |
STANDARD |
RESULTS |
|
Appearance |
yellow crystalline powder,odorless |
Conforms |
|
Solubility |
Easily soluble in water, unsoluble in ethanol |
Conforms |
|
PH |
6.0~7.5 |
6.9 |
|
Solution clarity and color |
solution should be clear and colorless |
Conforms |
|
Related substances |
5’CMP 0.3% Simple impurity Total other impurity |
0.01% 0.03% 0.10% |
|
Chloride |
0.05% |
Conforms |
|
Ammonium |
0.05% |
Conforms |
|
Fe |
0.01% |
Conforms |
|
Phosphate |
0.1% |
Conforms |
|
Loss on drying |
≤6.0% |
1.3% |
|
Heavy metals |
0.002% |
Conforms |
|
Arsenide |
0.0001% |
Conforms |
|
Bacterial Endotoxins |
0.3EU/mg |
Conforms |
|
Microbial Limit |
Conforms |
Conforms |
|
Assay(on dried basis) |
≥98.0% |
98.8% |
|
Conclusion |
The results conform with BP 2010 |
|
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
