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    Ciclopirox Topical Solution

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    ehsan050628

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    © All Rights Reserved
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    Ciclopirox Topical Solution

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    ehsan050628
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    Ciclopirox Topical Solution

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    Printed on: Sat Jun 26 2021, 05:44:56 PM Official Status: Currently Official on 26-Jun-2021 DocId: 1_GUID-68FDE415-24CF-4385-B54B-3C0445CBF73D_1_en-US

    (EST)
    Printed by: Nguyen Nhan Official Date: Official Prior to 2013 Document Type: USP @2021 USPC
    1

    Acceptance criteria: 90.0%–110.0%


    Ciclopirox Topical Solution
    PERFORMANCE TESTS
    DEFINITION • MINIMUM FILL á755ñ: Meets the requirement
    Ciclopirox Topical Solution contains NLT 90.0% and NMT
    110.0% of the labeled amount of ciclopirox (C12H17NO2). IMPURITIES
    • ORGANIC IMPURITIES
    IDENTIFICATION Buffer, Mobile phase, Standard solution, Sample
    • A. The retention time of the major peak of the Sample solution, Chromatographic system, and System
    solution corresponds to that of the Standard solution, as suitability: Proceed as directed in the Assay.
    obtained in the Assay. Analysis
    Sample: Sample solution
    ASSAY
    Calculate the percentage of each impurity in the portion of
    • PROCEDURE
    Topical Solution taken:
    [NOTE—Protect the Standard solution and Sample
    solution from light.] Result = (rU/rT) × (1/F) × 100
    Buffer: Transfer 5.25 g of citric acid and 25 mL of 0.1 M
    edetate disodium to a 1-L volumetric flask, and dilute with rU = peak response of each individual impurity from
    water to volume. Adjust with 8.5% diluted sodium the Sample solution
    hydroxide solution to a pH of 6.5. rT = sum of responses of all the peaks in the Sample
    Mobile phase: Acetonitrile and Buffer (35:65) solution
    Standard solution: 0.2 mg/mL of USP Ciclopirox RS and 1 F = relative response factor (see Table 1)
    µg/mL each of USP Ciclopirox Related Compound B RS and
    USP Ciclopirox Related Compound C RS in methanol Acceptance criteria: See Table 1.

    al
    Sample solution: Equivalent to 0.2 mg/mL of ciclopirox in
    methanol from Topical Solution. Pass through a filter of Table 1
    0.45-µm pore size, and use the filtrate.
    Relative Relative Acceptance
    Chromatographic system Retention Response Criteria,
    (See Chromatography á621ñ, System Suitability.) Compound Time Factor NMT (%)
    Mode: LC
    Detector: UV 303 nm
    Column: 4-mm × 12.5-cm; 5-µm packing L1
    ci Ciclopirox related com-
    pound C 0.54 1.3 0.5

    Column temperature: 30 ± 5° Ciclopirox 1.0 — —


    Flow rate: 0.9 mL/min Ciclopirox related com- — —
    ffi
    Run time: 5 times the retention time of the major peak pound Ba 1.87
    Injection size: 20 µL
    Any unspecified individu- —
    System suitability al impurity 1.0 0.2
    Sample: Standard solution
    [NOTE—For information only, see Table 1 for relative Total impurities — — 1.2
    retention times of impurities.] a Process impurity already monitored in the drug substance.
    O

    Suitability requirements
    Resolution: NLT 3.0 between ciclopirox and ciclopirox
    related compound B; and NLT 3.0 between ciclopirox SPECIFIC TESTS
    related compound C and ciclopirox • MICROBIAL ENUMERATION TESTS á61ñ and TESTS FOR
    Tailing factor: NMT 2.0 for the ciclopirox peak SPECIFIED MICROORGANISMS á62ñ: The total aerobic
    Relative standard deviation: NMT 2.0% for the microbial count does not exceed 102 cfu/g, and the total
    ciclopirox peak combined molds and yeasts count does not exceed 101 cfu/
    Analysis g.
    Samples: Standard solution and Sample solution ADDITIONAL REQUIREMENTS
    Calculate the percentage of the labeled amount of • PACKAGING AND STORAGE: Preserve in well-closed
    ciclopirox (C12H17NO2) in the portion of Topical Solution containers, protected from light. Store at controlled room
    taken: temperature.
    • USP REFERENCE STANDARDS á11ñ
    Result = (rU/rS) × (CS/CU) × 100 USP Ciclopirox RS
    USP Ciclopirox Related Compound B RS
    rU = peak response from the Sample solution 6-Cyclohexyl-4-methyl-2-pyrone.
    rS = peak response from the Standard solution C12H16O2 192.25
    CS = concentration of USP Ciclopirox RS in the USP Ciclopirox Related Compound C RS
    Standard solution (mg/mL) 6-Cyclohexyl-4-methylpyridin-2(1H)-one.
    CU = nominal concentration of ciclopirox in the Sample C12H17NO 191.27
    solution (mg/mL)

    https://online.uspnf.com/uspnf/document/1_GUID-68FDE415-24CF-4385-B54B-3C0445CBF73D_1_en-US 1/1

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