| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
|
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| Items | Standards | Results |
| Appearance | White crystalline powder, odourless, hygroscopic | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Melting Point | 160.0ºC~167.0ºC | 164.0ºC~165.0ºC |
| Specific Rotation | -25°~-29° | -25.7° |
| Loss on Drying | ≤ 0.50% | 0.07% |
| Residue on Ignition | ≤ 0.10% | 0.02% |
| Heavy Metals | ≤ 20ppm | Complies |
| Chloride | ≤ 0.01% | Complies |
| Enantiomer | ≤ 0.15% | UN |
| Diastereomer | ≤ 0.15% | UN |
| Residual Solvent | M'ethanol: ≤ 3000ppm | UN |
| I'sopropanol: ≤ 5000ppm | 1085ppm | |
| C'hlorobenzene: ≤ 5000ppm | UN | |
| Related Substances | Any single impurity: ≤0.10% | Complies |
| Total impurities: ≤0.50% | 0.06% | |
| Purity | ≥ 99.5% | 99.94% |
| Assay | 98.0%~102.0%(calculated on the dried basis) | 99.10% |
| Reference Standard | In-house Standard | |
| Conclusion | The product complied to In-house standard. | |
| Storage | Preserve in tight,light-resistant containers, protect from moisture and store below 25ºC | |
Description:
Ezetimibe is a drug that lowers plasma cholesterol levels. It acts by decreasing cholesterol absorption in the small intestine. It may be used alone (marketed as Zetia or Ezetrol), when other cholesterol-lowering medications are not tolerated, or together with statins (e.g., ezetimibe/simvastatin, marketed as Vytorin and Inegy) when statins alone do not control cholesterol.
Ezetimibe is recommended as second line therapy for those intolerant of statins or unable to achieve target LDL cholesterol levels on statins alone by several major medical group practice guidelines, but not by those of the American Heart Association and American College of Cardiology.
While ezetimibe reduces LDL cholesterol, it has not been shown to have an impact on outcomes such as risk of death or major cardiovascular event like heart attack or stroke. Its effectiveness in reducing atherosclerosis in clinical trials has been inconsistent. The question of whether ezetimibe could make a difference in major outcomes was examined in the IMPROVE-IT trial, which compared treatment with ezetimibe vs. placebo on top of a background regimen of statin therapy in people who have had recent episodes of acute coronary syndrome over a six-year period. The trial results showing that ezetimibe treatment lowered the risk of experiencing a vascular event by 2%.
Ezetimibe Function:
1) Ezetimibe reduces the amount of cholesterol absorbed by the body.
2) Ezetimibe is used to treat high cholesterol.
3) Ezetimibe is sometimes given with other cholesterol-lowering medications.
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