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Nicorandil is a vasodilatory drug used to treat angina.
Nicorandil stimulates guanylate cyclase to increase formation of cyclic GMP (cGMP).cGMP activates protein kinase G (PKG) which phosphorylates and inhibits GTPase RhoA and decreases Rho-kinase activity. Reduced Rho-kinase activity permits an increase in myosin phosphatase activity, decreasing the calcium sensitivity of the smooth muscle.
Specification:
|
Analysis Test |
Specification |
Result |
|
Description |
white 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. |
