Scribd Logo
Upload

Welcome to Scribd!

  • 14 views

    USP2024... Acepromazine Maleate Tablets

    Uploaded by

    Neeraj Singh
    This document provides procedures for identifying and determining the quantity of acepromazine maleate in tablets through liquid chromatography. Key steps include extracting the active ingredient from powdered tablets and running samples and standards on a chromatography system using specific parameters. The percentage of labeled acepromazine maleate content in the tablets is calculated for comparison to acceptance criteria of 90-110%. Additional requirements specify packaging, storage, and labeling of the veterinary tablets.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    USP2024... Acepromazine Maleate Tablets

    Uploaded by

    Neeraj Singh
    14 views1 page
    This document provides procedures for identifying and determining the quantity of acepromazine maleate in tablets through liquid chromatography. Key steps include extracting the active ingredient from powdered tablets and running samples and standards on a chromatography system using specific parameters. The percentage of labeled acepromazine maleate content in the tablets is calculated for comparison to acceptance criteria of 90-110%. Additional requirements specify packaging, storage, and labeling of the veterinary tablets.

    Original Title

    USP2024...Acepromazine Maleate Tablets

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document provides procedures for identifying and determining the quantity of acepromazine maleate in tablets through liquid chromatography. Key steps include extracting the active ingredient from powdered tablets and running samples and standards on a chromatography system using specific parameters. The percentage of labeled acepromazine maleate content in the tablets is calculated for comparison to acceptance criteria of 90-110%. Additional requirements specify packaging, storage, and labeling of the veterinary tablets.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    14 views1 page

    USP2024... Acepromazine Maleate Tablets

    Uploaded by

    Neeraj Singh
    This document provides procedures for identifying and determining the quantity of acepromazine maleate in tablets through liquid chromatography. Key steps include extracting the active ingredient from powdered tablets and running samples and standards on a chromatography system using specific parameters. The percentage of labeled acepromazine maleate content in the tablets is calculated for comparison to acceptance criteria of 90-110%. Additional requirements specify packaging, storage, and labeling of the veterinary tablets.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    Printed on: Fri Jan 05 2024, 10:02:53 PM(EST) Status: Currently Official on 06-Jan-2024 DocId: GUID-7D2E5BBC-B41E-4FC6-B8B6-ABE8E8312EDD_2_en-US

    Printed by: USP NF Official Date: Official as of 01-May-2020 Document Type: USP @2024 USPC
    Do Not Distribute DOI Ref: 2mw76 DOI: https://doi.org/10.31003/USPNF_M140_02_01
    1

    Sample solution: Nominally 0.1 mg/mL of Acepromazine


    Acepromazine Maleate Tablets Maleate in water from Sample stock solution. Pass a portion
    DEFINITION of this solution through a filter of 0.5-µm or finer pore size.
    Acepromazine Maleate Tablets contain NLT 90.0% and NMT Chromatographic system
    110.0% of the labeled amount of acepromazine maleate (See Chromatography á621ñ, System Suitability.)
    (C19H22N2OS · C4H4O4). Mode: LC
    Detector: UV 280 nm
    Throughout the following procedures, protect samples, the
    Column: 4-mm × 15-cm; 5-µm packing L7
    USP Reference Standard, and solutions containing them, by
    Flow rate: 1 mL/min
    conducting the procedures without delay, under subdued
    Injection volume: 10 µL
    light, or using low-actinic glassware.
    System suitability
    IDENTIFICATION Sample: Standard solution
    Suitability requirements
    Change to read: Column efficiency: NLT 1500 theoretical plates
    Tailing factor: NMT 2.5
    • A. ▲SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared Relative standard deviation: NMT 2.0%
    Spectroscopy: 197K▲ (CN 1-May-2020) Analysis
    Sample: To a quantity of powdered Tablets, equivalent to Samples: Standard solution and Sample solution
    20 mg of acepromazine maleate, add 2 mL of water and Calculate the percentage of acepromazine maleate
    3 mL of 2 N sodium hydroxide, and extract with two 5-mL (C19H22N2OS · C4H4O4) in the portion of Tablets taken:
    portions of cyclohexane. Combine the cyclohexane
    extracts, and evaporate to dryness under vacuum, using Result = (rU/rS) × (CS/CU) × 100
    gentle heat if necessary.

    al
    Acceptance criteria: Meet the requirements rU = peak area from the Sample solution
    • B. The retention time of the major peak of the Sample rS = peak area from the Standard solution
    solution corresponds to that of the Standard solution, as
    obtained in the Assay. CS = concentration of USP Acepromazine Maleate RS
    in the Standard solution (mg/mL)
    ASSAY CU = nominal concentration of the Sample solution
    • PROCEDURE
    Buffer: Add 6 mL of triethylamine to 700 mL of water, and
    adjust with phosphoric acid to a pH of 2.5.
    ci (mg/mL)

    Acceptance criteria: 90.0%–110.0%


    Mobile phase: Acetonitrile and Buffer (300:700)
    ADDITIONAL REQUIREMENTS
    Standard stock solution: 1 mg/mL of USP Acepromazine
    ffi
    • PACKAGING AND STORAGE: Preserve in tight, light-resistant
    Maleate RS in 0.05 N hydrochloric acid
    containers, and store at controlled room temperature.
    Standard solution: 0.1 mg/mL of USP Acepromazine
    • LABELING: Label the Tablets to indicate that they are for
    Maleate RS in water from Standard stock solution
    veterinary use only.
    Sample stock solution: Transfer NLT 10 Tablets to a 200-mL
    • USP REFERENCE STANDARDS á11ñ
    volumetric flask, add 100 mL of 0.05 N hydrochloric acid,
    USP Acepromazine Maleate RS
    and sonicate for 10 min. Shake by mechanical means for
    O

    30 min, and dilute with 0.05 N hydrochloric acid to volume.

    https://online.uspnf.com/uspnf/document/1_GUID-7D2E5BBC-B41E-4FC6-B8B6-ABE8E8312EDD_2_en-US 1/1

    You might also like