| Function: | Cardiovascular Agents |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
| Type: | Analysis reagent |
| State: | Solid |
| Volatile: | Not Volatile |
| Samples: |
|---|
| Customization: |
|---|
Suppliers with verified business licenses
Audited Supplier | Name | Simvastatin |
| CAS NO. | 79902-63-9 |
|
Molecular Formula |
C25H38O5 |
|
Molecular Weight |
418.57 |
|
Melting Point |
139 °C |
|
EINECS |
404-520-2 |
| Appearance | White Crystalline powder |
| Purity | 99% Min |
Simvastatin is a hypolipidemic drug used with exercise, diet, and weight-loss to control elevated cholesterol, or hypercholesterolemia.
It is a member of the statin class of pharmaceuticals. Simvastatin is a synthetic derivative of a fermentation product of Aspergillus terreus.
Certification
|
Appearance |
White or almost white, crystalline powder |
White crystalline powder |
|
Specific rotation |
Meet the requirement |
Complies |
|
IR |
IR spectrum of sample conforms to that of the reference standard |
Complies |
|
Appearance of solution |
The solution is clear and not more intensely colored than reference solution BY7 |
Complies |
|
Specific optical rotation |
+285o~+300o |
+288.4o |
|
Sum of impurities E and F |
Not more than 1.0% |
0.26% |
|
Sum of Impurities B and C |
Not more than 0.8% |
0.18% |
|
Impurity A |
Not more than 0.4% |
0.03% |
|
Impurity D |
Not more than 0.4% |
0.17% |
|
Impurity G |
Not more than 0.4% |
0.13% |
|
Unspecified impurity |
Not more than 0.10% |
0.08% |
|
Sum of impurities (other than E and F ) |
Not more than 1.0% |
0.72% |
|
Heavy mentals |
Not more than 20ppm |
Less than 20ppm |
|
Loss on drying |
Not more than 0.5% |
0.08% |
|
Sulfated ash |
Not more than 0.1% |
0.03% |
|
Ethanol |
Not more than 5000ppm |
588ppm |
|
Assay (on the dried basis ) |
97.0% to 102.0% of C25H38 O5 |
100.10% |
|
Conclusion |
The results conform with the specifications |
|
Simvastatin (INN) is a hypolipidemic drug used with exercise, diet, and weight-loss to control elevated
cholesterol, or hypercholesterolemia. It is a member of the statin class of pharmaceuticals.
(1) The primary uses of simvastatin are for the treatment of dyslipidemia and the prevention of cardiovascular
disease.
(2) It also can used for the patient with coronary heart disease.
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Audited Supplier 
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