Product Name: Simvastatin
Chemical Name:
1s-(1-alpha,3-dro-4-hydroxy-6-oxo-2h-pyran-2-yl)ethyl)-1-naphthalenyleste(7-beta,8-beta(2s*,4s*),8a-beta))-alph
CAS NO.: 79902-63-9
EINECS NO.: 404-520-2
Molecular Formula:C25H38O5
Formula Weight:418.57
Structural formula:
Properties:
Appearance and solubility: White crystalline powder,odorless. Practically insoluble in water, freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane.
Density: 1.11 g/cm3
Melting point: 139 ºC
Boiling point: 564.9 139 ºC at 760 mmHg
Flash point: 184.8 139 ºC
Refractive index: 1.53
Quality Specification: USP35,≥98.0%
|
TESTS |
SPECIFICATION |
RESULTS |
||
|
Characters |
white or almost white powder |
Conforms |
||
|
Identification |
A.IR |
Conforms |
Conforms |
|
|
|
B.the retention time of the |
Conforms |
Conforms |
|
|
Specific rotation |
+285° ~ +298° |
+291.5° |
||
|
Solubility |
Practically insoluble in water; freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane |
Conforms |
||
|
Loss on drying % |
≤0.5% |
0.25% |
||
|
Residue on ignition % |
≤0.1% |
0.02% |
||
|
Heavy Metals % |
≤0.001 |
Conform |
||
|
Related Substance |
Simvastatin hydroxyacid |
≤0.4% |
0.06 |
|
|
Epilovastatin and Lovastatin |
≤1.0% |
0.26 |
||
|
Methylene simvastatin |
≤0.4% |
0.07 |
||
|
Acetyl simvastatin |
≤0.4% |
0.06 |
||
|
Anhydro simvastatin |
≤0.4% |
0.06 |
||
|
Simvastatin dimer |
≤0.4 |
0.08 |
||
|
Any other individual impurity |
≤0.1% |
Complies |
||
|
Total impurities other than lovastatin and epilovastatin |
≤0.1% |
0.36 |
||
|
Assay %(on dried basis) |
98.0-102.0 |
99.4 |
||
|
Conclusion: Complies with USP35 |
||||
Application:
1. HMG-CoA reductase inhibitors, can reduce the concentration of serum total cholesterol level, inhibit synthesis of cholesterol. For treatment of primary hypercholesterolemia with cholesterol levels greater than 7.8mmol/L which is invalid or not tolerated in other treatments.
2. Has role in reducing cholesterol, low-density lipoprotein cholesterol and very low density lipoprotein cholesterol.