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    Wa0005.

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    Khotibul Umam

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    Wa0005.

    Uploaded by

    Khotibul Umam
    6 views1 page

    Original Title

    DOC-20240605-WA0005.

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    6 views1 page

    Wa0005.

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    Khotibul Umam

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    Printed on: Fri Jan 05 2024, 09:37:31 PM(EST) Status: Currently Official on 06-Jan-2024 DocId: GUID-BB9F33F9-3399-4A4E-9075-8350FD744EAD_4_en-US

    Printed by: USP NF Official Date: Official as of 01-May-2020 Document Type: USP @2024 USPC
    Do Not Distribute DOI Ref: cx7ic DOI: https://doi.org/10.31003/USPNF_M48030_04_01
    1

    CS = concentration of USP Mefenamic Acid RS in the


    Mefenamic Acid Standard solution (mg/mL)
    CU = concentration of Mefenamic Acid in the Sample
    solution (mg/mL)

    Acceptance criteria: 98.0%–102.0% on the dried basis

    C15H15NO2 241.29 IMPURITIES


    • RESIDUE ON IGNITION á281ñ: NMT 0.1%
    Benzoic acid, 2-(2,3-dimethylphenyl)amino-;
    • ORGANIC IMPURITIES
    N-2,3-Xylylanthranilic acid CAS RN®: 61-68-7; UNII:
    Buffer, Mobile phase, and Chromatographic system:
    367589PJ2C.
    Proceed as directed in the Assay.
    DEFINITION Standard solution: 0.01 mg/mL of USP Mefenamic Acid
    Mefenamic Acid contains NLT 98.0% and NMT 102.0% of RS in Mobile phase
    mefenamic acid (C15H15NO2), calculated on the dried basis. Sensitivity solution: 0.3 µg/mL of USP Mefenamic Acid RS
    in Mobile phase from the Standard solution
    IDENTIFICATION Sample solution: 1 mg/mL of Mefenamic Acid in Mobile
    • A. ▲SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared phase
    Spectroscopy: 197K or 197A▲ (CN 1-May-2020) System suitability
    • B. The retention time of the major peak of the Sample Samples: Standard solution and Sensitivity solution
    solution corresponds to that of the Standard solution, as Suitability requirements
    obtained in the Assay. Tailing factor: NMT 1.6, Standard solution
    ASSAY Relative standard deviation: NMT 5.0%, Standard

    al
    • PROCEDURE solution
    Buffer: 50 mM monobasic ammonium phosphate. Adjust Signal-to-noise ratio: NLT 10, Sensitivity solution
    with 3 M ammonium hydroxide to a pH of 5.0. Analysis
    Mobile phase: Acetonitrile, tetrahydrofuran, and Buffer Samples: Standard solution and Sample solution
    (23:7:20)
    ci Calculate the percentage of each impurity in the portion of
    Standard solution: 0.2 mg/mL of USP Mefenamic Acid RS Mefenamic Acid taken:
    in Mobile phase
    Result = (r U/r S) × (C S/C U) × 100
    Sample solution: 0.2 mg/mL of Mefenamic Acid in Mobile
    phase rU = peak response of each impurity from the Sample
    Chromatographic system solution
    ffi
    (See Chromatography á621ñ, System Suitability.) rS = peak response of mefenamic acid from the
    Mode: LC Standard solution
    Detector: UV 254 nm CS = concentration of USP Mefenamic Acid RS in the
    Column: 4.6-mm × 25-cm; 5-µm packing L1 Standard solution (mg/mL)
    Flow rate: 1 mL/min CU = concentration of Mefenamic Acid in the Sample
    Injection volume: 10 µL solution (mg/mL)
    O

    System suitability
    Sample: Standard solution Acceptance criteria: The reporting threshold is 0.03%.
    Suitability requirements Any impurity: NMT 0.07%
    Column efficiency: NLT 8200 theoretical plates Total impurities: NMT 0.5%
    Tailing factor: NMT 1.6
    Relative standard deviation: NMT 0.73% SPECIFIC TESTS
    Analysis • LOSS ON DRYING á731ñ
    Samples: Standard solution and Sample solution Analysis: Dry at 105° for 4 h.
    Calculate the percentage of mefenamic acid (C15H15NO2) in Acceptance criteria: NMT 1.0%
    the portion of Mefenamic Acid taken: ADDITIONAL REQUIREMENTS
    Result = (r U/r S) × (C S/C U) × 100 • PACKAGING AND STORAGE: Preserve in tight, light-resistant
    containers.
    rU = peak response of mefenamic acid from the • USP REFERENCE STANDARDS á11ñ
    Sample solution USP Mefenamic Acid RS
    rS = peak response of mefenamic acid from the
    Standard solution

    https://online.uspnf.com/uspnf/document/1_GUID-BB9F33F9-3399-4A4E-9075-8350FD744EAD_4_en-US 1/1

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