Pharm-Rx Quetiapine Fumarate

Chemical Name: Quetiapine Fumarate

CAS Number: 111974-72-2

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    Enhanced TDS

    Identification & Functionality

    Chemical Name
    Molecular formula
    (C₂₁H₂₅N₃O₂S)₂· C₄H₄O₄
    Technologies
    Product Families
    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

    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 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.