Simvastatin
CAS Number: 79902-63-9
Molecular Formula: C25H38O5
Standard: USP32
Package:25kg/drum
ITEMS | LIMIT |
Characteristic | A white to off-white crystalline powder |
Identification | IR: Meet the requirement |
HPL: Meet the requirement | |
Solubility | Meet the requirement |
Specific optical rotation | +285°~ + 298° |
Heavy Metals | NMT 0.002% |
Loss on drying | NMT 0.5% |
Chromatographic purity | Simvastatin hydroxyacid NMT 0.4% |
Methylene simvastatin NMT 0.4% | |
Acetyl simvastatin NMT 0.4% | |
Simvastatin dimer NMT 0.4 | |
Any other individual impurity NMT 0.1% | |
Lovastatin and epilovastatin NMT 1.0% | |
Total impurities (except Lovastatin & epilovastatin) NMT 1.0% | |
Residue on ignition | NMT 0.1% |
Residual solvents | Dichloromethane NMT 600ppm |
Alcohol NMT 5000ppm | |
Assay (on dried basis) | 98.0 ~ 102.0% |