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    Miconazole

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    ghofrane ekvl

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    Miconazole

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    ghofrane ekvl
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    Miconazole

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    Printed on: Sun Jul 25 2021, 05:27:17 PM Official Status: Currently Official on 25-Jul-2021 DocId: 1_GUID-CBC3DB8F-D3F0-48C2-830A-DEC447B9A2C8_4_en-US

    (EST)
    Printed by: Le Tran Official Date: Official as of 01-May-2020 Document Type: USP @2021 USPC
    1

    Titrant: 0.1 N perchloric acid VS


    Miconazole Endpoint detection: Visual
    Analysis: Titrate the Sample solution with Titrant to a green
    endpoint. Perform a blank determination, and make any
    necessary correction. Each mL of 0.1 N perchloric acid is
    equivalent to 41.61 mg of miconazole (C18H14Cl4N2O).
    Acceptance criteria: 98.0%–102.0% on the dried basis
    IMPURITIES
    • RESIDUE ON IGNITION á281ñ: NMT 0.2%
    • ORGANIC IMPURITIES
    Standard solution A: 10 mg/mL of USP Miconazole RS in
    chloroform
    Standard solution B: 100 µg/mL of USP Miconazole RS
    from Standard solution A in chloroform
    Sample solution: 10 mg/mL in chloroform
    Chromatographic system
    (See Chromatography á621ñ, Thin-Layer Chromatography.)
    Mode: TLC
    Adsorbent: 0.25-mm layer of chromatographic silica gel
    mixture
    C18H14Cl4N2O 416.13 Application volume: 5 µL
    1H-Imidazole, 1-2-[(2,4-dichlorophenyl)-2-[(2,4- Developing solvent system: n-Hexane, chloroform,

    al
    dichlorophenyl)]methoxy]ethyl]-, (±)-; methanol, and ammonium hydroxide (60:30:10:1)
    (±)-1-[2,4-Dichloro-β-[(2,4-dichlorobenzyl)oxy] phenethyl] Analysis
    imidazole [22916-47-8]. Samples: Standard solution A, Standard solution B, and
    Sample solution
    DEFINITION ci Apply the Samples separately to the starting line of the
    Miconazole contains NLT 98.0% and NMT 102.0% of plate. Develop the chromatogram in a suitable chamber
    miconazole (C18H14Cl4N2O), calculated on the dried basis. with freshly prepared Developing solvent system until the
    IDENTIFICATION solvent front has moved about three-fourths of the
    length of the plate. Remove the plate from the chamber,
    Change to read: and allow the solvent to evaporate. Expose the plate to
    ffi
    iodine vapors in a closed chamber for 30 min, and locate
    • A. ▲SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared the spots.
    Spectroscopy: 197K▲ (CN 1-May-2020) Acceptance criteria: The R F value of the principal spot from
    • B. the Sample solution corresponds to that from Standard
    Sample solution: Dissolve 40 mg in 50 mL of isopropyl solution A, and any other spot from the Sample solution does
    alcohol in a 100-mL volumetric flask, and add 10 mL of not exceed, in size or intensity, the principal spot from
    O

    0.1 N hydrochloric acid. Dilute with isopropyl alcohol to Standard solution B (1.0%).
    volume.
    Acceptance criteria: The UV absorption spectrum of the SPECIFIC TESTS
    Sample solution exhibits maxima and minima at the same • LOSS ON DRYING á731ñ
    wavelengths as that of a similar solution of USP Analysis: Dry a sample under vacuum at 60° for 4 h.
    Miconazole RS, concomitantly measured. Acceptance criteria: NMT 0.5%
    ASSAY ADDITIONAL REQUIREMENTS
    • PROCEDURE • PACKAGING AND STORAGE: Preserve in well-closed
    Sample solution: 300 mg of Miconazole in 40 mL of glacial containers, protected from light. Store at 25°, excursions
    acetic acid. Add 4 drops of p-naphtholbenzein TS. permitted between 15° and 30°.
    Titrimetric system • USP REFERENCE STANDARDS á11ñ
    Mode: Direct titration USP Miconazole RS

    https://online.uspnf.com/uspnf/document/1_GUID-CBC3DB8F-D3F0-48C2-830A-DEC447B9A2C8_4_en-US 1/1

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