Test items

Specifications

Appearance

White to off-white powder

Solubility

Practically insoluble in water, freely soluble in chloroform, in methanol, and in alcohol; sparingly soluble in propyleneglycol; very sightly soluble in hexane

Identification

IR should be conformed

HPLC should be conformed

Specific optical rotation

+285°~ +298°

Heavy metals

≤20ppm

Loss on drying

≤0.5%

Assay on dry basis

98.0%~102.0%

Chromatography purity

    Simvastatin hydroxyacid

    Lovastatin and epilovastatin

    Methylene simvastatin

    Acetyl simvastatin

    Anhydro simvastatin

    Simvastatin dimer

    Any other individual impurity

    Total impurities

(Except lovastatin and epilovastatin)

≤0.4%

≤1.0%

≤0.4%

≤0.4%

≤0.4%

≤0.4%

≤0.10%

≤1.0%

Residual organic solvents

Methanol

Ethanol

Methylene chloride

≤3000ppm

≤5000ppm

≤600ppm