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147098-20-2 Rosuvastatin Rosuvastatin Calcium
CAS No.: 147098-20-2
Name: Rosuvastatin calcium
Formula: 2(C22H27FN3O6S).Ca
Molecular Weight: 1001.14
Synonyms:7-{4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoic acid;
Melting Point: 122 °C
Boiling Point: 745.6 °C at 760 mmHg
Flash Point: 404.7 °C
Appearance: white to off-white crystalline powder
Application: Severe chronic thyroid deficiency (mucous edema), cretinism, and also can be used for diagnosis of thyroid function
Rosuvastatin Calcium
Test |
Specification |
Appearance |
white to off-white Powder |
Specific rotation |
+170~+210 |
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% |
Sulphates |
≤0.1% |
Enantiomer |
≤0.15% |
Calcium |
3.9%~4.3% |
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 impurities ≤0.50% |
|
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) |
Particle size |
D(0.1) <5μm |
D(0.5) <10μm |
|
D(0.9) <20μm |
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