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
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Time

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