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Atorvastatin Calcium

A selective, competitive HMG-CoA reductase . Atorvastatin is the only drug in its class specfically indicated for lowering both elevated LDL-cholesterol and triglyceinhibitorrides in patients with hypercholesterolemia.

  • Features & Specification

    PRODUCT   NAME

    Atorvastatin Calcium

    CAS   No.:

    134523-03-8

    Synonyms:

    Atorvastatin Calcium Salt;

    Atorvastatin calcium salt trihydrate;

    Formula:

    C66H68CaF2N4O10

    Molecular   Weight:

    1155.34000

    PSA:

    201.58000

    LogP:

    12.61900

     

    Structure

    image.png                  

     

    Description

    Appearance   & Physical State:

    White   Crystalline Powder

    Melting   Point:

    176-178ºC

    Boiling   Point:

    722.2ºC   at 760 mmHg

    Flash   Point:

    390.6ºC

    Safety   Statements:

    S26;   S36

    HS   Code:

    2933990090

    Risk   Statements:

    R20/21/22

    Hazard   Codes:

    Xn

     

    Certificate of Analysis

     

    ProductName: Atorvastatin Calcium

    Cas:       134523-03-8

    Batch No.:     201402001

    MFG Date:  Feb.11.2014

    Analysis Date:Feb.12.2014

    Expiry Date: Feb.10.2016

    Inspect   Item

    Quantity   Standard

    Inspection   Result

    Appearance

    White   or off- white  powder.

    Conforms  

    Assay  

    98.0-102.0%(calculated   to anhydrous substance)

    99.4%

    Identification  

    IR,Calcium

    Conforms  

    Water  

    3.5-5.5%

    4.6%

    Heavy   Metals

    20ppmMAX

    <20ppm

    Enantiomer   atorvastatin Calcium E

    0.3%Max

    0.01%

    Related   substance

    Impurity   A

     Impurity B

    ImpurityC

    Impurity   D

    Unspecified   impurity

       Total

    0.3%MAX

    0.3%MAX

    0.3%MAX

    0.1%MAX

    0.1%MAX

    1.0%MAX

    0.1%

    0.02%

    0.01%

    0.05%

    0.04%

    0.4%

    Residual   solvents

    Ethanol

    Toluene

    N-hexane

    5000ppmMAX

    890ppmMAX

    290ppmMAX

    ND

    98ppm

    20ppm

    Bioburden

    Total   Aerobic Microbial Count

    Total   combined Mold and Yeast Count

    Escheriche   coli

    1000CFU/gMAX

    100CFU/gMAX

    Negative

    <10CFU/g

    <100CFU/g

    ND

    Conclusion  

    In   accordance with USP35 standard


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