Simvastatin
Basic Info
Model No.: USP
Product Description
TEST | STANDARD | RESULT |
Characters | White to off-white powder | A white powder |
Identification |
| Conforms |
| Conforms | |
Specific optical rotation | +285--+298° | +290° |
|
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 % | 0.04% |
Residue on Ignition | ≤0.1% | 0.04% |
Heavy Metals | ≤20ppm | <20ppm |
Chromatographic purity | ||
Simvastatin hydroxyacid | ≤0.4% | 0.09 |
Lovastatin and epilovastatin | ≤1.0% | 0.38% |
Methylene simvastation | ≤0.4% | 0.09% |
Acetyl simvastatin | ≤0.4% | 0.05% |
Anhydro simvastatin | ≤0.4% | 0.10% |
Simvastatin dimer | ≤0.4% | 0.11% |
Any other individual impurity | ≤0.10% | 0.03% |
Total impurities (except lovastatin and epilovastatin) | ≤1.0% | 0.52% |
| Residual organic solvents Methanol Ethanol Methylene chloride |
≤3000ppm ≤5000ppm ≤600ppm |
ND 574ppm ND |
Assay (on dry basis) | 98.0—102.0% | 99.3% |
Conclusion | It complies with all the requirements of USP34 | |
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Product Categories : Pharmaceutical Raw Materials
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