Product Information |
Product name |
Azilsartan Medoxomil Potassium; (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-oxo-3-((2’-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-[1,1’-biphenyl]-4-yl)methyl)-2,3-dihydro-1H-benzo[d]imidazole-4-carboxylate |
CAS No. |
1417576-00-1 |
Molecular Formula |
C28H20N4O8 |
Molecular Weight |
540.489 |
Quality Standard |
98% up by HPLC |
Appearance |
White or almost white crystalline powder |
COA
|
ANALYSIS |
SPECIFICATION |
RESULTS |
Appearance |
White or almost white crystalline powder |
White crystalline powder |
Solubility |
Practically insoluble in water |
Conforms |
Identification |
The retention time of the main peak should be consistent with the RS |
Conforms |
The infrared absorption spectrum is concordant with that of RS |
Conforms |
|
It gives the reaction of potassium(2). |
Positive |
|
Related substances |
Impurity C ≤ 0.15% |
ND |
Impurity A ≤ 1.5% |
0.2% |
|
Unspecified impurities ≤ 0.10% |
0.04% |
|
Total impurities ≤ 2.0% |
0.4% |
|
2-Ethylhexanoic acid |
≤0. 5% |
0.20% |
Residual solvents |
Ethanol ≤ 0.5% |
ND |
Acetone ≤ 0.5% |
0.01% |
|
Dichloromethane ≤ 0.06% |
ND |
|
Tert-Butylmethyl ether ≤ 0.5% |
0.10% |
|
Tetrahydrofuran ≤ 0.072% |
ND |
|
n-Heptane ≤ 0.5% |
ND |
|
Butyl acetate ≤ 0.5% |
ND |
|
Water |
≤ 0.5% |
0.09% |
Heavy metals |
≤ 20ppm |
Conforms |
Assay |
≤98.0% - 102.0%(anhydrous substance) |
99.7% |
Conclusion |
The sample complies with the Requirements of In House Specifications. |
Usage |
Compared to traditional sartan antihypertensive drugs, Azilsartan Medoxomil Potassium, with its unique oxadiazole ring structure, exhibits an affinity for angiotensin II receptors that is increased by over 10,000 times. Additionally, it binds more tightly to the receptor and dissociates more slowly, thereby exerting a potent, stable, and long-lasting antihypertensive effect. Furthermore, Azilsartan Medoxomil Potassium contains a unique pH modifier, which makes it unaffected by gastric acid upon oral administration, effectively enhancing drug stability and solubility.
While effectively controlling blood pressure, Azilsartan Medoxomil Potassium also offers cardiovascular and renal protective effects. Clinical studies have shown that, in addition to having significantly better antihypertensive efficacy than valsartan and olmesartan, Azilsartan Medoxomil Potassium also outperforms valsartan and olmesartan in reversing cardiac hypertrophy, stabilizing atherosclerotic plaques, resisting myocardial fibrosis, improving insulin resistance, reducing urine protein, and protecting the kidneys.