| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
|
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Description:
Edarbi (azilsartan medoxomil), a prodrug, is hydrolyzed to azilsartan in the gastrointestinal tract during absorption. Azilsartan is a selective AT1 subtype angiotensin II receptor antagonist. The drug substance used in the drug product formulation is the potassium salt of azilsartan medoxomil, also known by the US accepted name of azilsartan kamedoxomil and is chemically described as (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylate monopotassium salt.
Uses:
Azilsartan and chlorthalidone combination is used to treat high blood pressure (hypertension). Azilsartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. As a result, azilsartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
Certificate of Analysis
| EM | SPECIFICATION |
RESULT |
Appearance |
White to off-white powder |
White powder |
Identification |
Correspond to reference chromatograph |
Conform |
Purity(HPLC) |
≥99.0% | 99.72% |
Max single impurity |
≤ 0.1% | 0.09% |
Total impurities |
≤ 0.5% | 0.28% |
Isomer |
≤ 0.1% | 0.006% |
Assay(HPLC) |
≥98.0% | 99.6% |
Loss on drying |
≤ 1.0% | 0.77% |
| Moisture content |
≤ 1.0% | 0.33% |
Residue On Ignition |
≤0.2% | 0.05% |
Heavy metal |
≤ 20ppm | Conform |
Specific optical rotation |
+6.5°-- +8.5° | +7.34° |
Result |
Qualified | |
Storage |
Sealed,avoid light,at room temperature. | |
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