Pharm-Rx Atorvastatin Calcium

Chemical Name: Atorvastatin Calcium

CAS Number: 344423-98-9

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    Identification & Functionality

    Chemical Name
    Molecular formula
    Product Families
    Chemical Structure

    Pharm-Rx Atorvastatin Calcium - Chemical Structure - 1


    Atorvastatin Calcium contains NLT 98.0% and NMT 102.0% of atorvastatin calcium (C66H68CaF2N4O10), calculated on the anhydrous and solvent-free basis. If labeled as a propylene glycol solvate, it contains NLT 98.0% and NMT 102.0% of atorvastatin calcium (C66H68CaF2N4O10), calculated on the anhydrous, propylene glycol-free, and solvent-free basis. It may contain a suitable antioxidant.

    Applications & Uses


    Typical Properties
    ValueUnitsTest Method / Conditions
    Molecular Weight1155.36--

    Regulatory & Compliance

    FDA Disclaimer

    These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

    USP Reference Standards

    USP Atorvastatin Calcium RS
    USP Atorvastatin Related Compound A RS Calcium (3R,5R)-7-[2-isopropyl-4,5-diphenyl-3-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2);
    Also known as Desfluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-2-isopropyl-4,5-diphenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoicacid, calcium salt.

    C₆₆H₇₀CaN₄O₁₀ 1119.38
    USP Atorvastatin Related Compound B RS Calcium (3S,5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); also known as 3S,5R
    Isomer, or (3S,5R)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
    C₆₆H₆₈CaF₂N₄O₁₀ 1155.34
    USP Atorvastatin Related Compound C RS Calcium (3R,5R)-7-[2,3-Bis(4-fluorophenyl)-5-isopropyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); Also known as Difluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-4,5-bis(4-fluorophenyl)-2-isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
    C₆₆H₆₆CaF₄N₄O₁₀  1191.34
    USP Atorvastatin Related Compound D RS 3-(4-Fluorobenzoyl)-2-isobutyryl-N,3-diphenyloxirane-2-carboxamide; Also known as Epoxide impurity, or 3-(4-fluorobenzoyl)-2-isobutyryl-3-phenyl-oxirane-2-carboxylic acid phenylamide.
    C₂₆H₂₂FNO₄  431.46

    USP Atorvastatin Related Compound E RSCalcium (3S,5S)-7-[2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); Also known as 3S,5S Enantiomer, or (3S,5S)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
    C₆₆H₆₈CaF₂N₄O₁₀ 1155.36
    ▲USP Atorvastatin Related Compound H RS Also known as Lactone impurity;▲ (ERR 1-Jun-2023)5-(4-Fluorophenyl)-1-{2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl}-2-isopropyl-N,4-diphenyl-1H-pyrrole-3-carboxamide.
    C33H33FN2O4 540.64

    ▲USP Atorvastatin Related Compound I RS Also known as Acetonide impurity;▲ (ERR 1-Jun-2023)tert-Butyl 2-((4R,6R)-6-{2-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl)acetate.
    C40H47FN2O5  654.82

    Storage & Handling

    Storage Information
    • Preserve the trihydrate form in well-closed containers, and store at room temperature.
    • If labeled as amorphous or semicrystalline or as a propylene glycol solvate, store as per labeling instructions.

    Possible packaging and storage conditions could include the following: Preserve in well-closed containers protected from light and moisture, or in tight containers; store at room temperature, at controlled room temperature, or at 2 °C - 8 °C; store under nitrogen atmosphere or packed with an oxygen absorber; and store under nitrogen atmosphere, packed with silica gel and an oxygen absorber.