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  • Product Name :

    Rosuvastatin Calcium

  • CAS No. :147098-20-2
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Product Details

ROSUVASTATIN CALCIUM

Chemical Name

7-{4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoic acid                   

CAS Number

147098-20-2

Molecular Formula

C44H54CaF2N6O12S2

Molecular Structure

TN1Y5(RP@ILZAI[0$(P4TC3.png

Packing

1kg/carton

Capacity

Production upon order

Storage

Kept in well-closed container, protected from light

Application

It is used to high blood pressure, high cholesterol


SPECIFICATION

ITEMS

SPECIFICATION

Appearance

A white to off-white powder

Identification

Meets the requirements

Specific Rotation

+15.0°~ +21.0°

Chloride

≤0.1%

Sulphate

≤0.1%

Enantiomer

≤0.5%

Related Substances

Diastereomers ≤0.5%
     5-oxo-Rosuastatin ≤0.3%
     Photodegradation impurity 1≤0.3%
     Photodegradation impurity 2 ≤0.3%
     Rosuvastatin lactone ≤0.3%
     Rosuvastatin tert-butyl ≤0.3%
     Any unknown impurity: ≤0.2%
     Total impurities ≤1.0%

Water

≤3.0%

Heavy Metals

≤0.002%

Residual Solvents

Methanol ≤0.3%
     Ethyl ether ≤0.5%
     Acetone ≤0.5%
     Acetonitrile ≤0.041%
     Toluene ≤0.089%
     Isopropyl ether ≤0.5%
     Ethyl acetate ≤0.5%
     Tetrahydrofuran ≤0.072%
     Tert-butyl alcohol ≤0.5%
     Acetic acid ≤0.5%

Assay (on dried basis)

98.5 ~ 102.0%

Standard

Factory Standard


Our manufacturing process for Rosuvastatin Calcium is according to the basic patent process. One of the steps has been changed according to our technique, It is non-infringement patent product. Our workshop is EU GMP approval and we can support DMF for registration. We filed DMF at US FDA as well.

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