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  • Dissolution

    Transféré par

    Aji nur pangestu
    13 vues3 pages
    for younger aduult

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    for younger aduult

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    13 vues3 pages

    Dissolution

    Transféré par

    Aji nur pangestu
    for younger aduult

    Droits d'auteur :

    © All Rights Reserved
    Téléchargez comme XLS, PDF, TXT ou lisez en ligne sur Scribd
    Signaler comme contenu inapproprié
    sur 3

    USP Dissolution Test Apparatus II (Paddle) 1/31/2018 3:55

    Group Members:
    Capsule Formulation:
    Tablet Formulation: 500 mg Acetaminophen Tablets

    Analyte: Acetaminophen
    Capsule Dose: 999 mg
    Tablet Dose: 999 mg
    Wavelength: 999 nm
    Calibration Curve Parameters:
    Slope: 999 (Enter the slope from the calibration curve here)
    Intercept: 999 (Enter the intercept from the calibration curve here)
    Assay Dilution Factor: 50 X (Dilution factor: 1:50)
    V Dissolution Medium: 500 mL

    Time Drug Concentration Amount Released % Released Similarity


    OD999 OD999 (mg/L) (mg) (mg) Factors
    (min) Capsule Tablet Capsule Tablet Capsule Tablet Capsule Tablet f1 f2
    999 999.0000 999.0000 0.0000 0.0000 0.0000 0.0000 0.0 0.0 0.00 0.00
    999 999.0000 999.0000 0.0000 0.0000 0.0000 0.0000 0.0 0.0 0.00 0.00
    999 999.0000 999.0000 0.0000 0.0000 0.0000 0.0000 0.0 0.0 0.00 0.00
    999 999.0000 999.0000 0.0000 0.0000 0.0000 0.0000 0.0 0.0 0.00 0.00
    999 999.0000 999.0000 0.0000 0.0000 0.0000 0.0000 0.0 0.0 0.00 0.00
    999 999.0000 999.0000 0.0000 0.0000 0.0000 0.0000 0.0 0.0 0.00 0.00
    999 999.0000 999.0000 0.0000 0.0000 0.0000 0.0000 0.0 0.0 0.00 0.00

    Absorbance vs. Time Concentration vs. Time


    Acetaminophen Acetaminophen
    1200.0000 1.0000
    0.9000
    Concentration (mg/L)

    1000.0000 0.8000
    0.7000
    OD999

    800.0000
    0.6000
    600.0000 0.5000
    0.4000
    400.0000 Capsule 0.3000 Capsule
    Tablet 0.2000 Tablet
    200.0000
    0.1000
    0.0000 0.0000
    800 1000 1200 Time (min) 1600
    1400 1800 2000 800 1000 1200 Time 1400
    (min) 1600 1800 2000
    A m ount R e leas ed (m g)

    Dissolution Curve:
    % Released vs. Time
    1.0 Acetaminophen
    % Released

    Amount Released vs. Time 0.9


    Acetaminophen
    1.0000 0.8
    0.9000
    0.7
    0.8000
    0.6
    0.7000
    0.6000 0.5
    0.5000 0.4
    0.4000 0.3 Capsule
    0.3000 Capsule 0.2 Tablet
    0.2000 Tablet
    0.1
    0.1000
    0.0
    0.0000
    800 1000 1200Time 1400
    (min) 1600 1800 2000 800 1000 1200 Time (min)
    1400 1600 1800 2000

    f1: #DIV/0! (PASS: 0-15)


    f2: 100.00 (PASS: 50-100)
    #DIV/0!
    Source: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm07023
    oryInformation/Guidances/ucm070237.pdf

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