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    Shelf-Life FDA Ovais

    Uploaded by

    Ovais08
    This spreadsheet could be used for detemination of shelf-life (expiration dating period) for pharmaceutical products as per FDA/ICH guidelines. The spreadsheet calculates shelf-life for a single batch stability data only. Help: If you think the spreadsheet is useful, please help me to write macro (VBA) for it.

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    Attribution Non-Commercial No-Derivs (BY-NC-ND)
    Download as XLS, PDF, TXT or read online from Scribd

    Shelf-Life FDA Ovais

    Uploaded by

    Ovais08
    1K views8 pages
    This spreadsheet could be used for detemination of shelf-life (expiration dating period) for pharmaceutical products as per FDA/ICH guidelines. The spreadsheet calculates shelf-life for a single batch stability data only. Help: If you think the spreadsheet is useful, please help me to write macro (VBA) for it.

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    © Attribution Non-Commercial No-Derivs (BY-NC-ND)

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    This spreadsheet could be used for detemination of shelf-life (expiration dating period) for pharmaceutical products as per FDA/ICH guidelines. The spreadsheet calculates shelf-life for a single batch stability data only. Help: If you think the spreadsheet is useful, please help me to write macro (VBA) for it.

    Copyright:

    Attribution Non-Commercial No-Derivs (BY-NC-ND)
    Download as XLS, PDF, TXT or read online from Scribd
    Download as xls, pdf, or txt
    1K views8 pages

    Shelf-Life FDA Ovais

    Uploaded by

    Ovais08
    This spreadsheet could be used for detemination of shelf-life (expiration dating period) for pharmaceutical products as per FDA/ICH guidelines. The spreadsheet calculates shelf-life for a single batch stability data only. Help: If you think the spreadsheet is useful, please help me to write macro (VBA) for it.

    Copyright:

    Attribution Non-Commercial No-Derivs (BY-NC-ND)
    Download as XLS, PDF, TXT or read online from Scribd
    Download as xls, pdf, or txt
    You are on page 1of 8

    Product Example

    Batch Number 123


    Statistical Evaluation of Stability Data Add Company Name/Logo Here
    Storage condition 25°C/60%RH Shelf-life Estimation for Single Batch (as per
    User Ovais ICH/FDA) Date 23/02/2007 t(n-2, α/2) =

    Lower specification limit = 90 % This spreadsheet is the property of the author and may not be sold or
    Upper specification limit = 110 % distributed without author's permission. Please request author
    % Confidence = 90 % (mohammad@xepasp.com) for any changes required to be made.

    Stability Data Analysis of Variance Table for the Stability Data


    Time Assay Source df SS MS F P-Value
    Months (%) Regression 1 -54411.3215 -54411.3215 16.3308 0.0037
    0 103.50 Residual 8 54507.5968 6813.4496
    1 104.00 Total 9 96.2752
    3 102.00
    6 101.85 Results of Least Squares Estimation of Slope and Intercept
    9 100.25 Predictor Coefficient SE t-stat P-Value Hypothesis
    12 101.00 Intercept 102.273 0.872 14.081 0.0000 Accepted
    18 95.00 Slope -0.139 0.034 -4.041 0.0037 Accepted
    24 98.50 Conclusion Shelf-life can be defined
    48 97.25
    54 95.00 1
    For quadratic eqn.: a = 509.372
    1 b = -109052.548
    c = ###
    1 D = b2-4*a*c = Real Roots
    D = b2-4*a*c = ###
    1
    Roots of the eqn.: XL = 64.770
    1
    XU = 149.322
    Assay

    0
    0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1
    Summary Statistics
    Regression Statistics Time
    R² 0.6712
    Adjusted R² 0.6301
    Error Variance 1.9892 Shelf-Life 64.770 months
    Copyright @ Mohammad Ovais, Pharmaceutical Scientist.
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    Assay

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    100
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    96
    95
    0 5 10 15 20 25 30 35 40 45 50 55
    Time

    Column C
    55

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