Shelf-life Fda Ovais
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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
Statistical Evaluation of Stability Data
Add Company Name/Logo Here
Shelf-life Estimation for Single Batch (as per ICH/FDA)
Date 23/02/2007
This spreadsheet is the property of the author and may not be sold or distributed without author's permission. Please request author ([email protected]) for any changes required to be made.
90 % 110 % 90 %
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
For quadratic eqn.:
a b c D = b2-4*a*c D = b2-4*a*c
1 1
Assay
1
Roots of the eqn.:
1
= 509.372 = -109052.548 = ### = Real Roots = ###
XL =
64.770
XU =
149.322
0 0 0 0 0 0
Summary Statistics Regression Statistics R² 0.6712 Adjusted R² 0.6301 Error Variance 1.9892
t(n-2, α/2) =
0
0.1
0.2
0.3
0.4
0.5
Time
Shelf-Life
64.770
months
0.6
0.7
0.8
0.9
1
Copyright @ Mohammad Ovais, Pharmaceutical Scientist.
Assay
104 104 103 103 102 102 101 101 100 100 99 99 98 98 97 97 96 96 95
0
5
10
15
20
25
30
Time Column C
35
40
45
50
55
55
Data Assay (%) 103.50 104.00 102.00 101.85 100.25 101.00 95.00 98.50 97.25 95.00
Statistical Evaluation of Stability Data
Add Company Name/Logo Here
Shelf-life Estimation for Single Batch (as per ICH/FDA)
Date 23/02/2007
This spreadsheet is the property of the author and may not be sold or distributed without author's permission. Please request author ([email protected]) for any changes required to be made.
90 % 110 % 90 %
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
For quadratic eqn.:
a b c D = b2-4*a*c D = b2-4*a*c
1 1
Assay
1
Roots of the eqn.:
1
= 509.372 = -109052.548 = ### = Real Roots = ###
XL =
64.770
XU =
149.322
0 0 0 0 0 0
Summary Statistics Regression Statistics R² 0.6712 Adjusted R² 0.6301 Error Variance 1.9892
t(n-2, α/2) =
0
0.1
0.2
0.3
0.4
0.5
Time
Shelf-Life
64.770
months
0.6
0.7
0.8
0.9
1
Copyright @ Mohammad Ovais, Pharmaceutical Scientist.
Assay
104 104 103 103 102 102 101 101 100 100 99 99 98 98 97 97 96 96 95
0
5
10
15
20
25
30
Time Column C
35
40
45
50
55
55
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