Simvastatin

Short Description:



Simvastatin
CAS Number: 79902-63-9
Molecular Formula: C25H38O5
Standard: USP32
Package:25kg/drum

Description:



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%


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