Rosuvastatin Calcium manufacturer CAS:147098-20-2
Sep 10th, 2022 at 04:23 Electronic Chemicals Naperville 50 views Reference: K4oeElwgd0BLocation: Naperville
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Storage conditions: -20°C Freezer
Items of Analysis | Standard of Analysis | Test Results | ||
Appearance | Off-white to pale yellow powder | Off-white powder | ||
Specific rotation(°) | +13.0~+18.0 | +17.9 | ||
Identification | IR | Consistent with the reference | Consistent with the reference | |
Calcium salt | Positive response | Positive response | ||
GC | The main peak retention time consistent with thereference | The main peak retention time consistent with thereference | ||
Water (%,w/w) | ≤3.0 | 2.5 | ||
Loss on drying (%,w/w) | ≤3.0 | 1.7 | ||
Relative Substance (%,area,HPLC) | Single impurity | ≤0.10 | <0.05 | |
Total impurity | ≤1.0 | <0.05 | ||
Diastereomer (EP Imp.B) | ≤0.15 | <0.05 | ||
EP Imp.A | ≤0.10 | Not detected | ||
5-Keto acid (EP Imp.C) | ≤0.10 | <0.05 | ||
Assay (%, ESTD, HPLC) | 98.0-102.0 | 99.7 | ||
Conclusion | ConformstoFactory Standard |
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