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    Albendazole

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    Vu An

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    © All Rights Reserved
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    Albendazole

    Uploaded by

    Vu An
    7 views1 page

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    © © All Rights Reserved

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    Albendazole

    Uploaded by

    Vu An

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    © All Rights Reserved
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    Printed on: Wed Feb 08 2023, 11:46:41 PM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-9A018C96-C082-47EB-AF74-F276C1A094F5_4_en-US

    Printed by: Dang Van Vu Official Date: Official as of 01-May-2020 Document Type: USP @2023 USPC
    Do Not Distribute DOI Ref: 09cxx DOI: https://doi.org/10.31003/USPNF_M1150_04_01
    1

    • ORGANIC IMPURITIES
    Albendazole Standard stock solution: 5 mg/mL of USP Albendazole RS
    in glacial acetic acid
    Standard solution: 0.05 mg/mL of USP Albendazole RS in
    glacial acetic acid from Standard stock solution
    Sample solution: 10 mg/mL in glacial acetic acid
    Chromatographic system
    C12H15N3O2S 265.33 (See Chromatography á621ñ, Thin-Layer Chromatography.)
    Carbamic acid, [5-(propylthio)-1H-benzimidazol-2-yl]-, Mode: TLC
    methyl ester; Adsorbant: 0.25-mm layer of silica gel mixture
    Methyl 5-(propylthio)-2-benzimidazolecarbamate Application volume: 10 µL
    CAS RN®: 54965-21-8; UNII: F4216019LN. Developing solvent system: Chloroform, ether, and
    DEFINITION glacial acetic acid (60:10:10)
    Albendazole contains NLT 98.0% and NMT 102.0% of Analysis: Proceed as directed for Chromatography á621ñ,
    albendazole (C12H15N3O2S), calculated on the dried basis. Thin-Layer Chromatography.
    Samples: Standard stock solution, Standard solution, and
    IDENTIFICATION Sample solution
    Develop the chromatogram in the Developing solvent
    Change to read: system until the solvent front has moved about
    • A. ▲SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared three-fourths of the length of the plate. Remove the plate
    Spectroscopy: 197M▲ (CN 1-May-2020) from the developing chamber, mark the solvent front,
    • B. The R F value of the principal spot of the Sample solution allow the solvent to evaporate from the plate, and

    al
    examine the plate under short-wavelength UV light.
    corresponds to that of the principal spot of the Standard
    Acceptance criteria: 0.5%; no spot, other than the principal
    solution, as obtained in the test for Organic Impurities.
    spot of the Sample solution, is larger or more intense than
    ASSAY the principal spot of the Standard solution.
    • PROCEDURE
    SPECIFIC TESTS
    Sample: 250 mg of Albendazole

    in 100 mL of glacial acetic acid, warming gently if


    necessary. Cool, and titrate with 0.1 N perchloric acid VS
    ci
    Analysis: Transfer the Sample to a suitable flask, and dissolve
    • LOSS ON DRYING á731ñ
    Analysis: Dry at 105° for 4 h.
    Acceptance criteria: NMT 0.5%
    to a potentiometric endpoint (see Titrimetry á541ñ). ADDITIONAL REQUIREMENTS
    Perform a blank determination. Each mL of 0.1 N perchloric • PACKAGING AND STORAGE: Preserve in tight containers, and
    ffi
    acid is equivalent to 26.53 mg of C12H15N3O2S. store at controlled room temperature.
    Acceptance criteria: 98.0%–102.0% on the dried basis • USP REFERENCE STANDARDS á11ñ
    USP Albendazole RS
    IMPURITIES
    • RESIDUE ON IGNITION á281ñ: NMT 0.2%
    O

    https://online.uspnf.com/uspnf/document/1_GUID-9A018C96-C082-47EB-AF74-F276C1A094F5_4_en-US 1/1
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