Rosuvastatin Calcium

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(3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic Acid Calcium Salt
Rosuvastatin Calcium Salt
Rosuvastatin Hemicalcium
ZD 4522 Calcium Salt
Rosuvastatin Calcium
Molecular Formula:  C44H54CaF2N6O12S2
Molecular Weight: 1001.14000

Appearance and properties: white to off-white crystalline solid
Boiling point: 745.6ºC at 760 mmHg
Melting point: 122ºC
Flash point: 404.7ºC

Storage conditions: -20°C Freezer

use:Lipid-lowering drugs.

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 the reference The main peak retention time consistent with the reference
≤3.0 2.5
Loss on drying
≤3.0 1.7
Relative Substance
Single impurity ≤0.10 <0.05
Total impurity ≤1.0 <0.05
(EP Imp.B)
≤0.15 <0.05
 EP Imp.A ≤0.10 Not detected
5-Keto acid
(EP Imp.C)
≤0.10 <0.05
98.0-102.0 99.7
Conclusion Conforms to Factory Standard

 Rosuvastatin Calcium

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