Test Item |
Analysis Specification |
Result |
Description |
A white or almost white crystalline power |
Conform |
Identification |
A: IR spectrum conforms to reference standard B: Retention time of main peak conforms to reference standard in HPLC
|
Conform
Conform
|
Loss on drying |
≤0.25% |
0.04% |
Residue on ignition |
≤0.1% |
0.02% |
Heavy metals |
≤0.001% |
Conform |
Related Substances |
A ≤0.1% B ≤0.1% C≤0.1% Individual impurity≤0.1% Total impurities≤0.4% |
0.02% 0.03% 0.02% 0.04% 0.1% |
Assay(HPLC) |
98.0%~102.0% |
99.6% |
Residual solvent |
Ethanol ≤5000ppm |
216ppm |
Particle size |
90% less than 20 um |
conform |
Consequence |
Conform to the specification of USP 32. |
Cilostazol is a quinolinone-derivative medication used in the alleviation of the symptoms of intermittent claudication in individuals with peripheral vascular disease.
Although drugs similar to cilostazol have increased the risk of death in patients with congestive heart failure, studies of significant size have not addressed people without the disease.
Function:
Cilostazol is a phosphodiesterase inhibitor with therapeutic focus on cyclic adenosine monophosphate (cAMP). It inhibits platelet aggregation and is a direct arterial vasodilator. Its main effects are dilation of the arteries supplying blood to the legs and decreasing platelet coagulation.
Cilostazol is approved for the treatment of intermittent claudication. The typical dose is 100 mg twice a day. The effects may take as long as 3 months to be evident and has been shown to improve pain-free walking distance by 50%. Cilostazol is also frequently used off-label, at the same dose, for treatment of intracranial atherosclerosis and secondary stroke prevention.
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