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Simvastatin

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SKU:ACS022
Description:

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    ITEMSLIMIT
    CharacteristicA white to off-white crystalline powder
    IdentificationIR: Meet the requirement

    HPL: Meet the requirement
    SolubilityMeet the requirement
    Specific optical rotation+285°~ + 298°
    Heavy MetalsNMT 0.002%
    Loss on dryingNMT 0.5%
    Chromatographic puritySimvastatin hydroxyacid NMT 0.4%
    Methylene simvastatin NMT 0.4%
    Acetyl simvastatin NMT 0.4%
    Simvastatin dimer NMT 0.4
    Any other individual impurity NMT 0.1%
    Lovastatin and epilovastatin NMT 1.0%
    Total impurities (except Lovastatin & epilovastatin) NMT 1.0%
    Residue on ignitionNMT 0.1%
    Residual solventsDichloromethane NMT 600ppm

    Alcohol NMT 5000ppm
    Assay (on dried basis)98.0 ~ 102.0%


    With lower cholesterol, low-density lipoprotein cholesterol and very low density lipoprotein cholesterol

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