97% up by HPLC, GMP, DMF, CEP, EP Rosuvastatin Calcium 147098-20-2

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:97% up by HPLC, GMP, DMF, CEP, EP Rosuvastatin Calcium 147098-20-2
CAS No.:147098-20-2
Standard:USP, BP, EP, JP, In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co.Ltd.

Basic Info
  • Grade: Pharmaceutical Grade

    Factory Location: Xiamen, Fujian

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East

  • Monthly Production Capacity: 1000kg

    Packaging Information: 25kg/drum 1kg/bottle

  • Delivery Lead Time: 7 days after payment

    Sample Provided: yes

    Payment Terms: L/L

     

    Product Information

     

    Product name

    Rosuvastatin Calcium

    CAS No.

    147098-20-2

    Molecular Formula

    C44H54CaF2N6O12S2

    Molecular Weight

    1001.14

    Quality Standard

    97% up by HPLC, GMP,DMF,CEP, EP

    Appearance

    White or almost white powder

     

    COA of Rosuvastatin calcium

     

    ITEMS

    SPECIFICATION

    RESULT

    Appearance

    White or almost white hygroscopic powder

    Conforms

     

    Identity

    IR: Similar to Reference Substance

    Conforms

    Enantiomeric purity

    Conforms

    It gives reaction (b) of calcium

    Positive reaction

     

     

    Related substance

    Impurity A ≤ 0.2%

    Impurity B ≤ 0.5%

    Impurity C ≤ 0.8%

    Unknown impurity ≤ 0.1%

    Total impurity ≤ 1.2%

    Undetected

    Undetected

    Undetected

    Undetected

    Undetected

    Enantiomer

    Impurity G ≤ 0.10%

    Undetected

    Water

    ≤ 0.60%

    1.2%

    Assay

    97.0~102.0%(anhydrous substance )

    99.9%

    Conclusion

    The results above meet all requirements under EP8.4

     

    Usage

     

    Function of Rosuvastatin calcium

    Rosuvastatin calcium is an anti-hyperlipidemia drug which belongs to the inhibitor of HMG-CoA reductase successfully. It is suitable for the treatment of various lipid abnormalities, including hypercholesterolemia, mixed lipid qualitative abnormalities and simple hypertriglyceridemia. Rosuvastatin calcium is listed as the strongest and the most comprehensive statins drugs which has entered into market for lipid-lowering and adjustment. Compared with atorvastatin which is currently recognized with the world's best efficacy, it has a better effect of lowering the level of LDL cholesterol and increasing the level of high-density lipoprotein. Moreover, it has a better tolerance, lower side effects and unique pharmacokinetic characteristics with the half-life about 20h. It only needs to be taken once a day.

     

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