Rosuvastatin calcium ≥98.0% made in china CAS NO.147098-20-2

Appearance 

A white to off-white powder

Specific rotation 

+17°~ +21°

Identification 

A  meets the requirement 

B  UV: λmax=243nm

C  IR: similar to reference substance

D  X-ray diffraction: similar to reference spectrum

Chlorides

≤0.1%

Calcium 

3.9-4.3%

Sulphates 

≤0.1%

Enantiomer 

≤0.15%

Related substances 

Diastereomer 

≤0.15%

TP-13 impurity 1 

≤0.15%

Rosuvastatin lactone

≤0.15%

Rosuvastatin methyl ester

≤0.15%

Light degradation impurity 1

≤0.15%

Light degradation impurity 2

≤0.15%

Rosuvastatin isoamyl ester

≤0.15%

Any unknown impurity

≤0.10%

Total impurity

≤0.75%

Water 

≤3.0%

Heavy metals 

≤0.002%

Residual solvents

Ethyl ether 

≤300ppm

Acetonitrile 

≤410ppm

DMF

≤880ppm

Isoamyl alcohol

≤5000ppm

Isoamyl bromide 

≤37.5ppm

Acetates 

≤3000ppm(calculated on the CH3COOH basis)

Benzene 

≤2ppm

Residual palladium 

≤10ppm

Residual chromium 

≤25ppm

Assay 

98.5-102.0%(calculated on the anhydrous basis)