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Pharm-Rx Quetiapine Fumarate

Chemical Name: Quetiapine Fumarate

CAS Number: 111974-72-2

    Knowde Enhanced TDS

    Identification & Functionality

    Chemical Name
    Molecular formula
    (C₂₁H₂₅N₃O₂S)₂· C₄H₄O₄
    Chemical Structure

     - 1

    Definition

    Quetiapine Fumarate contains NLT 98.0% and NMT 102.0% of quetiapine fumarate [(C₂₁H₂₅N₃O₂S)₂ · C₄H₄O₄], calculated on the dried basis.

    Applications & Uses

    Properties

    Typical Properties
    ValueUnitsTest Method / Conditions
    Molecular Weight883.09

    Regulatory & Compliance

    USP Reference Standards
    • USP Quetiapine Fumarate RS
    • USP Quetiapine Related Compound B RS 11-(Piperazin-1-yl)dibenzo[b,f][1,4]thiazepine. C17H17N3S 295.40
    • USP Quetiapine Related Compound G RS Dibenzo[b,f][1,4]thiazepin-11(10H)-one. C13H,NOS 227.28
    • USP Quetiapine System Suitability RS: It contains quetiapine fumarate and NLT 0.1% of each of the following impurities: Quetiapine related compound B: 11-(Piperazin-1-yl)dibenzo[b,f][1,4]thiazepine; Quetiapine related compound G: Dibenzo[b,f][1,4] thiazepin-11(10H)-one; and Quetiapine desethoxy: 2-[4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl] ethanol.

    Storage & Handling

    Storage Information

    Preserve in well-closed containers, protected from light.