Pharm-Rx Mirtazapine

Chemical Name: Mirtazapine

CAS Number: 85650-52-8

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    Enhanced TDS

    Identification & Functionality

    Chemical Name
    Molecular formula
    C₁₇H₁₉N₃
    Chemical Structure

     - 1

    Definition

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

    Applications & Uses

    Properties

    Typical Properties
    ValueUnitsTest Method / Conditions
    Molecular Weight265.35

    Regulatory & Compliance

    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.