Product Example Batch Number 123 Storage condition 25°C/60%RH User Ovais Lower specification limit = Upper

specification limit = % Confidence = Stability Time Months 0 1 3 6 9 12 18 24 48 54 Data Assay (%) 103.50 104.00 102.00 101.85 100.25 101.00 95.00 98.50 97.25 95.00 90 % 110 % 90 %

Statistical Evaluation of Stability Data
Shelf-life Estimation for Single Batch (as per ICH/FDA)

Add Company Name/Logo Here Date 23/02/2007

t(n-2, α/2) =

This spreadsheet is the property of the author and may not be sold or distributed without author's permission. Please request author (mohammad@xepasp.com) for any changes required to be made. Analysis of Variance Table for the Stability Data Source df SS MS F Regression 1 -54411.3215 -54411.3215 16.3308 Residual 8 54507.5968 6813.4496 Total 9 96.2752

P-Value 0.0037

Results of Least Squares Estimation of Slope and Intercept Predictor Coefficient SE t-stat P-Value Hypothesis Intercept 102.273 0.872 14.081 0.0000 Accepted Slope -0.139 0.034 -4.041 0.0037 Accepted Conclusion Shelf-life can be defined
1 1 1 1

For quadratic eqn.:

a b c D = b2-4*a*c D = b2-4*a*c

= 509.372 = -109052.548 = ### = Real Roots = ### 64.770 149.322

Assay

1 0 0 0 0 0 0 0

Roots of the eqn.:

XL = XU =

Summary Statistics Regression Statistics R² 0.6712 Adjusted R² 0.6301 Error Variance 1.9892

0.1

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1

Time

Shelf-Life

64.770

months

Copyright @ Mohammad Ovais, Pharmaceutical Scientist.

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Assay

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Time
Column C

55

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