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    USP-NF Methylcobalamin Tablets

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    aqeel1970
    official monograph of USP methylcobalamin tablets

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    USP-NF Methylcobalamin Tablets

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    aqeel1970
    1 views2 pages
    official monograph of USP methylcobalamin tablets

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    official monograph of USP methylcobalamin tablets

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    © All Rights Reserved
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    Download as pdf or txt
    1 views2 pages

    USP-NF Methylcobalamin Tablets

    Uploaded by

    aqeel1970
    official monograph of USP methylcobalamin tablets

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    9/26/24, 1:07 PM USP-NF Methylcobalamin Tablets

    USP plans to conduct maintenance on the USP–NF/PF Online site beginning at 6pm EST on September 24th
    and completing on September 27th. Please note there may be minor service disruptions during this time.

    Printed on: Thu Sep 26 2024, 13:06:38 pm


    Printed by: UNEXO LABS
    Status: Currently Official on 26-Sep-2024
    Official Date: Official as of 01-Aug-2018
    Document Type: DIETARY SUPPLEMENTS
    DocId: GUID-A074C64E-60CD-48C3-80DC-C0B95E30623C_4_en-US
    DOI: https://doi.org/10.31003/USPNF_M7769_04_01
    DOI Ref: 08ug4
    Do not distribute
    © 2024 USPC

    Methylcobalamin Tablets
    DEFINITION
    Methylcobalamin Tablets contain NLT 90.0% and NMT 125.0% of the labeled amount of methylcobalamin (C63H91CoN13O14P).

    IDENTIFICATION
    • A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in Strength.

    STRENGTH
    • Procedure
    Buffer solution: 3.1 g/L of sodium dihydrogen phosphate dihydrate in water. Adjust with phosphoric acid (1 in 100) to a pH of 3.5.
    Mobile phase: Transfer 200 mL of acetonitrile to a 1-L volumetric flask and dilute with Buffer solution to volume. Then add 3.76 g of sodium 1-
    hexane sulfonate, and mix to dissolve.
    [Note—Use low-actinic glassware, and keep the following solutions from exposure to light.]

    Hydroxocobalamin Acetate RS in Mobile phase


    Standard solution: 100 µg/mL of USP Methylcobalamin RS in Mobile phase
    L
    System suitability solution: 0.05 mg/mL of cyanocobalamin from USP Cyanocobalamin (Crystalline) RS and 0.05 mg/mL of USP
    IA
    Sample solution: Finely powder NLT 30 Tablets. Transfer a portion of the powder, nominally equivalent to 5 mg of methylcobalamin, to a 50-mL
    volumetric flask, add a suitable amount of Mobile phase, swirl gently, and dilute with Mobile phase to volume. Shake vigorously for 10 min and
    immediately pass through a nylon membrane filter of 0.2-µm pore size.
    Chromatographic system
    IC

    (See Chromatography 〈621〉, System Suitability.)


    Mode: LC
    Detector: UV 266 nm
    Column: 4.6-mm × 25-cm; 5-µm packing L1
    Column temperature: 40°
    FF

    Flow rate: 0.6 mL/min


    Injection volume: 50 µL
    System suitability
    Samples: System suitability solution and Standard solution
    [Note—The relative retention times for cyanocobalamin and hydroxocobalamin are 0.8 and 1.0, respectively.]
    O

    Suitability requirements
    Resolution: NLT 3 between the cyanocobalamin and hydroxocobalamin peaks, System suitability solution
    Column efficiency: NLT 6000 theoretical plates, Standard solution
    Relative standard deviation: NMT 2.0%, Standard solution
    Analysis
    Samples: Standard solution and Sample solution
    Calculate the percentage of the labeled amount of methylcobalamin (C63H91CoN13O14P) in the portion of Tablets taken:

    Result = (rU/rS) × (CS/CU) × 100

    rU = peak response from the Sample solution

    rS = peak response from the Standard solution

    CS = concentration of USP Methylcobalamin RS in the Standard solution (µg/mL)

    CU = nominal concentration of methylcobalamin in the Sample solution (µg/mL)

    Acceptance criteria: 90.0%–125.0%

    https://online.uspnf.com/uspnf/document/1_GUID-A074C64E-60CD-48C3-80DC-C0B95E30623C_4_en-US?source=Search Results&highlight=m… 1/2


    9/26/24, 1:07 PM USP-NF Methylcobalamin Tablets
    PERFORMANCE TESTS
    • Disintegration and Dissolution 〈2040〉, Disintegration: Meet the requirements
    • Weight Variation 〈2091〉: Meet the requirements

    CONTAMINANTS
    • Microbial Enumeration Tests 〈2021〉: The total aerobic microbial count does not exceed 3 × 103 cfu/g, and the total combined molds and yeasts
    count does not exceed 3 × 102 cfu/g.
    • Absence of Specified Microorganisms 〈2022〉, Test Procedures, Test for Absence of Escherichia coli: Meet the requirements

    ADDITIONAL REQUIREMENTS
    • Packaging and Storage: Preserve in tight, light-resistant containers.
    • USP Reference Standards 〈11〉
    USP Cyanocobalamin (Crystalline) RS
    USP Hydroxocobalamin Acetate RS
    USP Methylcobalamin RS

    Auxiliary Information - Please check for your question in the FAQs before contacting USP.

    Topic/Question Contact Expert Committee

    METHYLCOBALAMIN TABLETS Natalia Davydova NBDS2020 Non-botanical Dietary


    Scientific Liaison Supplements

    Chromatographic Database Information: Chromatographic Database

    Most Recently Appeared In:


    Pharmacopeial Forum: Volume No. 43(3)
    L
    IA
    Page Information:

    USP43-NF38 - 5154
    USP42-NF37 - 5096
    USP41-NF36 1S - 8464

    Current DocID: GUID-A074C64E-60CD-48C3-80DC-C0B95E30623C_4_en-US


    IC

    Previous DocID: GUID-A074C64E-60CD-48C3-80DC-C0B95E30623C_2_en-US


    DOI: https://doi.org/10.31003/USPNF_M7769_04_01
    DOI ref: 08ug4
    FF
    O

    https://online.uspnf.com/uspnf/document/1_GUID-A074C64E-60CD-48C3-80DC-C0B95E30623C_4_en-US?source=Search Results&highlight=m… 2/2

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