| Customization: | Available |
|---|---|
| Function: | Antibiotic and Antimicrobial Agents |
| Certification: | GMP |
|
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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 |
Ethyl ether≤300ppm Undetected |
Complies |
|
Acetonitrile≤410ppm Undetected |
Undetected |
|
|
Isoamyl alcohol≤5000ppm Undetected |
Undetected |
|
|
DMF≤880ppm Undetected |
Undetected |
|
|
Assay |
98.5%~102.0%( caculated on the anhydrous basis) |
99.8% |
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