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PRODUCT CENTER
|
Product Name |
Simvastatin |
|
|
Applications |
Used to lower cholesterol levels in the blood, reducing the risk of heart disease and stroke. |
|
|
Typical Properties
|
Appearance |
White Crystalline Powder |
|
Identification |
i. IR |
|
|
Specific rotation |
+285° ~ +298° |
|
|
Loss on drying |
≤0.5% |
|
|
Residue on ignition |
≤0.1% |
|
|
Heavy metals |
≤0.002% |
|
|
Simvastatin hydroxyacid |
≤0.4% |
|
|
Epilovastatin and Lovastatin |
≤1.0% |
|
|
Methylene simvastatin |
≤0.4% |
|
|
Acety simvastatin |
≤0.4% |
|
|
Anhydro simvastatin |
≤0.4% |
|
|
Simvastatin dimer |
≤0.4% |
|
|
Individual Impurities |
≤0.1% |
|
|
Total impurities |
≤1.0% |
|
|
Assay (On dried basis) |
98.0 - 102.0% |
|
|
Product Name |
Simvastatin |
|
|
Applications |
Used to lower cholesterol levels in the blood, reducing the risk of heart disease and stroke. |
|
|
Typical Properties
|
Appearance |
White Crystalline Powder |
|
Identification |
i. IR |
|
|
Specific rotation |
+285° ~ +298° |
|
|
Loss on drying |
≤0.5% |
|
|
Residue on ignition |
≤0.1% |
|
|
Heavy metals |
≤0.002% |
|
|
Simvastatin hydroxyacid |
≤0.4% |
|
|
Epilovastatin and Lovastatin |
≤1.0% |
|
|
Methylene simvastatin |
≤0.4% |
|
|
Acety simvastatin |
≤0.4% |
|
|
Anhydro simvastatin |
≤0.4% |
|
|
Simvastatin dimer |
≤0.4% |
|
|
Individual Impurities |
≤0.1% |
|
|
Total impurities |
≤1.0% |
|
|
Assay (On dried basis) |
98.0 - 102.0% |
|
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