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    USP 2024... Acetaminophen For Effervescent Oral Solution

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    Neeraj Singh
    This document provides specifications for acetaminophen for effervescent oral solution, including: 1) It must contain between 5.63-6.88g of acetaminophen per 100g of solution. 2) Identification tests include confirming effervescence upon dissolution and matching retention times on thin-layer chromatography. 3) The assay uses HPLC to quantify the acetaminophen within 0.5% of the labeled amount. Performance tests include minimum fill requirements and uniformity of dosage units. The solution must also meet limits for impurities and be packaged and stored properly.

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    USP 2024... Acetaminophen For Effervescent Oral Solution

    Uploaded by

    Neeraj Singh
    80 views1 page
    This document provides specifications for acetaminophen for effervescent oral solution, including: 1) It must contain between 5.63-6.88g of acetaminophen per 100g of solution. 2) Identification tests include confirming effervescence upon dissolution and matching retention times on thin-layer chromatography. 3) The assay uses HPLC to quantify the acetaminophen within 0.5% of the labeled amount. Performance tests include minimum fill requirements and uniformity of dosage units. The solution must also meet limits for impurities and be packaged and stored properly.

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    USP 2024...Acetaminophen for Effervescent Oral Solution

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    This document provides specifications for acetaminophen for effervescent oral solution, including: 1) It must contain between 5.63-6.88g of acetaminophen per 100g of solution. 2) Identification tests include confirming effervescence upon dissolution and matching retention times on thin-layer chromatography. 3) The assay uses HPLC to quantify the acetaminophen within 0.5% of the labeled amount. Performance tests include minimum fill requirements and uniformity of dosage units. The solution must also meet limits for impurities and be packaged and stored properly.

    Copyright:

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

    USP 2024... Acetaminophen For Effervescent Oral Solution

    Uploaded by

    Neeraj Singh
    This document provides specifications for acetaminophen for effervescent oral solution, including: 1) It must contain between 5.63-6.88g of acetaminophen per 100g of solution. 2) Identification tests include confirming effervescence upon dissolution and matching retention times on thin-layer chromatography. 3) The assay uses HPLC to quantify the acetaminophen within 0.5% of the labeled amount. Performance tests include minimum fill requirements and uniformity of dosage units. The solution must also meet limits for impurities and be packaged and stored properly.

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    of 1

    Printed on: Fri Jan 05 2024, 09:52:05 PM(EST) Status: Currently Official on 06-Jan-2024 DocId: GUID-3E952614-C06A-4B1C-B9CB-DECF1225334F_1_en-US

    Printed by: USP NF Official Date: Official as of 01-Dec-2014 Document Type: USP @2024 USPC
    Do Not Distribute DOI Ref: grs61 DOI: https://doi.org/10.31003/USPNF_M183_01_01
    1

    Flow rate: 1.5 mL/min


    Acetaminophen for Effervescent Oral Injection volume: 10 µL
    Solution System suitability
    Sample: Standard solution
    DEFINITION Suitability requirements
    Acetaminophen for Effervescent Oral Solution contains, in Column efficiency: NLT 1000 theoretical plates
    each 100 g, NLT 5.63 g and NMT 6.88 g of acetaminophen Tailing factor: NMT 2.0
    (C8H9NO2). Relative standard deviation: NMT 2.0%
    Analysis
    IDENTIFICATION Samples: Standard solution and Sample solution
    • A. A 10-g portion dissolves, with effervescence, in water Calculate the quantity, in g, of acetaminophen (C8H9NO2)
    when dissolved as directed for the Sample solution in the
    in 100 g of Acetaminophen for Effervescent Oral Solution
    Assay.
    taken:
    • B. The retention time of the major peak of the Sample
    solution corresponds to that of the Standard solution, as Result = (rU/rS) × (CS/CU) × (1/F1) × L × F2
    obtained in the Assay.
    • C. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST rU = peak response from the Sample solution
    á201ñ rS = peak response from the Standard solution
    Sample solution: Triturate 0.4 g of the powder with 25 mL
    CS = concentration of USP Acetaminophen RS in the
    of methanol, and filter.
    Standard solution (mg/mL)
    Chromatographic system
    CU = nominal concentration of acetaminophen in the
    Developing solvent system: Methylene chloride and
    Sample solution (mg/mL)
    methanol (4:1)

    al
    F1 = conversion factor, 1000 mg/g
    Acceptance criteria: Meets the requirements
    L = label claim (mg/unit)
    ASSAY F2 = conversion factor, 100, based on the label claim
    • PROCEDURE of g of acetaminophen per 100 g of sample
    Mobile phase: Methanol and water (1:3)
    Standard solution: 0.01 mg/mL of USP Acetaminophen RS Acceptance criteria: 5.63–6.88 g
    in Mobile phase
    Sample stock solution: Dissolve 10 g of Acetaminophen for
    Effervescent Oral Solution in 200 mL of water in a 1000-mL
    ci PERFORMANCE TESTS
    • MINIMUM FILL á755ñ: Meets the requirements for solids
    volumetric flask, using gentle heat if necessary, until packaged in multiple-unit containers
    effervescence subsides, and then dilute with water to • UNIFORMITY OF DOSAGE UNITS á905ñ: Meets the
    ffi
    volume. requirements for solids packaged in single-unit containers
    Sample solution: Nominally 0.16 mg/mL of IMPURITIES
    acetaminophen in Mobile phase from the Sample stock • 4-AMINOPHENOL IN ACETAMINOPHEN-CONTAINING DRUG
    solution. Pass a portion of this solution through a filter of PRODUCTS á227ñ: Meets the requirements
    0.5-µm or finer pore size, discarding the first 10 mL of the
    filtrate. ADDITIONAL REQUIREMENTS
    O

    Chromatographic system • PACKAGING AND STORAGE: Preserve in air-tight containers,


    (See Chromatography á621ñ, System Suitability.) and store at controlled room temperature.
    Mode: LC • USP REFERENCE STANDARDS á11ñ
    Detector: UV 243 nm USP Acetaminophen RS
    Column: 3.9-mm × 30-cm; packing L1

    https://online.uspnf.com/uspnf/document/1_GUID-3E952614-C06A-4B1C-B9CB-DECF1225334F_1_en-US 1/1

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