Customization: | Available |
---|---|
Powder: | Yes |
Customized: | Customized |
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Tests |
Specifications |
Results |
Appearance |
A White to off-white powder |
Complies |
Specific Rotation |
+17°~+21° |
+20° |
Identification |
A. Meets the requirement B. UV: λmax=243nm C. IR: similar to Reference Substance D.X-ray: similar to Reference Substance |
Complies Complies Complies Complies |
Chloride |
≤0.1% |
Complies |
Sulphate |
≤0.1% |
Complies |
Enantiomer |
≤0.15% |
Undetected |
Calcium |
3.9%~4.3% |
4.1% |
Related substances |
Diastereomer≤0.15% |
0.06% |
5-oxo-Rosucastatin≤0.15% |
Undetected |
|
Photo degradation 1≤0.15% |
Undetected |
|
Photo degradation 2≤0.15% |
Undetected |
|
Rosuvastatin lactone≤0.15% |
Undetected |
|
Rosuvastatin methyl ester≤0.15% |
Undetected |
|
Rosuvastatin isoamyl ester≤0.15% |
Undetected |
|
Any unknown impurity≤0.10% |
0.05% |
|
Total impurities≤0.75% |
0.28% |
|
Water |
≤3.0% |
2.1% |
Isoamyl Bromide |
≤37.5ppm |
≤37.5ppm |
Residual solvents |
||
Isoamyl alcohol≤5000ppm Undetected |
Undetected |
|
DMF≤880ppm Undetected |
Undetected |
|
Assay |
98.5%~102.0%( caculated on the anhydrous basis) |
99.8% |