Pharm-Rx Mirtazapine

Chemical Name: Mirtazapine

CAS Number: 85650-52-8

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    Enhanced TDS

    Identification & Functionality

    Chemical Name
    Molecular formula
    Product Families
    Chemical Structure

     - 1


    Mirtazapine contains NLT 98.0% and NMT 102.0% of mirtazapine (C₁₇H₁₉N₃), calculated on the anhydrous basis.

    Applications & Uses


    Typical Properties
    ValueUnitsTest Method / Conditions
    Molecular Weight265.35--

    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 Mirtazapine RS
    • USP Mirtazapine Resolution Mixture RS Mirtazapine.
    • Impurity A: 1,2,3,4,10,14b-Hexahydro-2- methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine 2- oxide.
    • Impurity B: (2-(4-Methyl-2-phenylpiperazin-1-yl)pyridin- 3-yl)methanol.
    • Impurity C: (2-Methyl-3,4,10,14b-tetrahydrobenzo[c] pyrazino[1,2-a]pyrido[3,2-f]azepin-1(2H)-one.
    • Impurity D: [NOTE—This impurity may be available either as the free base form or as the hydrochloride salt form.] (ERR 1-Apr-2021) 1,2,3,4,10,14b- Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine or 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a] pyrido[2,3-c][2]benzazepine hydrochloride. (ERR 1-Apr-2021)
    • Impurity E: 4-Methyl-1-(3-methylpyridin-2-yl)-2- phenylpiperazine. Impurity F: 2-Methyl-1,2,3,4-tetrahydrobenzo[c] pyrazino[1,2-a]pyrido[3,2-f]azepin-10(14bH)-one.

    Storage & Handling

    Storage Information

    Preserve in tight containers, and store at controlled room temperature.