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1 Kilogram |
Negotiable |
Rosuvastatin calcium Rosuvastatin calcium
≥98.0%
Rosuvastatin calcium
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) |
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