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    Clorsulon (USP)

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    hang.oscar97

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    © All Rights Reserved
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    Clorsulon (USP)

    Uploaded by

    hang.oscar97
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    Clorsulon (USP)

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    Printed on: Sat Jun 26 2021, 06:05:14 PM Official Status: Currently Official on 26-Jun-2021 DocId: 1_GUID-2801304D-125F-4634-9F56-8E9ACAAE3B6B_4_en-US

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

    rU = peak response from the Sample solution


    Clorsulon rS = peak response from the Standard solution
    CS = concentration of USP Clorsulon RS in the Standard
    solution (mg/mL)
    CU = concentration of Clorsulon in the Sample solution
    (mg/mL)

    Acceptance criteria: 98.0%–101.0% on the dried basis


    IMPURITIES
    • RESIDUE ON IGNITION á281ñ: NMT 0.1%
    • ORGANIC IMPURITIES
    [NOTE—Store the Standard solutions and the Sample
    solution in low-actinic glassware.]
    C8H8Cl3N3O4S2 380.66 Standard solution A: 10 mg/mL of USP Clorsulon RS in
    1,3-Benzenedisulfonamide, 4-amino-6-(trichloroethenyl)-; methanol
    4-Amino-6-(trichlorovinyl)-m-benzenedisulfonamide Standard solution B: 0.1 mg/mL of USP Clorsulon RS in
    [60200-06-8]. methanol, from Standard solution A
    Sample solution: 10 mg/mL of Clorsulon in methanol
    DEFINITION Chromatographic system
    Clorsulon contains NLT 98.0% and NMT 101.0% of clorsulon (See Chromatography á621ñ, Thin-Layer Chromatography.)
    (C8H8Cl3N3O4S2), calculated on the dried basis. Mode: TLC
    Adsorbent: 0.25-mm layer of chromatographic silica gel

    al
    IDENTIFICATION mixture
    Change to read: Developing solvent system: Chloroform and methanol
    (4:1)
    • A. ▲SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared Analysis 1
    Spectroscopy: 197M▲ (CN 1-May-2020) Samples: Standard solution A, Standard solution B, and
    • B. The retention time of the major peak of the Sample
    solution corresponds to that of the Standard solution, as
    obtained in the Assay.
    ci Sample solution
    Apply 10 µL each of the Sample solution and Standard
    solution A, and 5 and 10 µL of Standard solution B. Allow
    the spots to dry. Develop in Developing solvent system until
    ASSAY the solvent front has moved three-fourths of the length of
    • PROCEDURE
    ffi
    the plate. Remove the plate, mark the solvent front, allow
    [NOTE—Store the Standard solution and the Sample the solvent to evaporate, and examine the plate under
    solution in low-actinic glassware.] short-wavelength UV light.
    Mobile phase: Acetonitrile, glacial acetic acid, and water Acceptance criteria 1: The chromatograms show principal
    (30: 0.1: 70) spots at the same R F value.
    Standard solution: 0.1 mg/mL of USP Clorsulon RS in
    Analysis 2: Estimate the amounts of any additional spots
    Mobile phase
    O

    observed in the chromatograms of the Sample solution in


    Sample stock solution: 1 mg/mL of Clorsulon in Mobile
    Analysis 1 by comparing them with the spots in the two
    phase
    chromatograms of Standard solution B, corresponding to
    Sample solution: 0.1 mg/mL of Clorsulon in Mobile phase, 0.5% and 1.0% of impurities.
    from the Sample stock solution
    Acceptance criteria 2
    Chromatographic system
    Any individual impurities: 0.5%; no spot other than the
    (See Chromatography á621ñ, System Suitability.)
    principal spot of the Sample solution is larger or more
    Mode: LC intense than that of the principal spot of the 5-µL
    Detector: UV 254 nm portion of Standard solution B.
    Column: 4.6-mm × 25-cm; packing L7 Total impurities: NMT 2.0%
    Flow rate: 1 mL/min
    Injection volume: 30 µL SPECIFIC TESTS
    System suitability • MELTING RANGE á741ñ: 197°–203°
    Sample: Standard solution • LOSS ON DRYING á731ñ
    Suitability requirements Analysis: Dry a sample under vacuum at 100° for 4 h.
    Column efficiency: NLT 7400 theoretical plates Acceptance criteria: NMT 0.5%
    Tailing factor: NMT 1.4
    Relative standard deviation: NMT 1.0% ADDITIONAL REQUIREMENTS
    Analysis • PACKAGING AND STORAGE: Preserve in well-closed
    Samples: Standard solution and Sample solution containers.
    Calculate the percentage of clorsulon (C8H8Cl3N3O4S2) in • LABELING: Label it to indicate that it is for veterinary
    the portion of Clorsulon taken: use only.
    • USP REFERENCE STANDARDS á11ñ
    Result = (r U/r S) × (C S/C U) × 100 USP Clorsulon RS

    https://online.uspnf.com/uspnf/document/1_GUID-2801304D-125F-4634-9F56-8E9ACAAE3B6B_4_en-US 1/1

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