Simvastatin

SKU : ACS022
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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%

With lower cholesterol, low-density lipoprotein cholesterol and very low density lipoprotein cholesterol

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