Product Batch Number Storage condition User

Example 123 25C/60%RH Ovais 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

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

Analysis of Variance Table for the Stability Data Source df SS Regression 1 64.6199 Residual 8 31.6554 Total 9 96.2753

MS 64.6199 3.9569

F 16.3308

P-Value 0.0037

Results of Least Squares Estimation of Slope and Intercept Predictor Coefficient SE t-stat Intercept 102.273 0.872 14.081 Slope -0.139 0.034 -4.041 Shelf-life can be defined Conclusion 120 100 80

P-Value 0.0000 0.0037

Hypothesis Accepted Accepted

Degradation line & 90% lower confidence limit for SS batch For quadratic eqn.: a = 509.372 b = -109052.548 c = 4926447.308 D = b2-4*a*c = Real Roots 2 Lower Specification D = b -4*a*c = 1854889110.341
Limit

Roots of the eqn.:

Assay

60 40
20 0 0 10 20 30

XL = XU =

64.770 149.322

Shelf-life = 64.770 months

40

50

60

70

80

Time
Summary Statistics Regression Statistics R 0.6712 Adjusted R 0.6301 Error Variance 1.9892
Assay Predicted Low_CL UP_CL

Shelf-Life

64.770

months

120

Degradation line & 90% lower confidence limit for SS batch

100
Lower Specification Limit

80

Assay

60

40

20

Shelf-life = 64.770 months

0

10
Assay

20

30

Time

40

50

60

70
Upper Confidence Limit

Degradation Curve

Lower Confidence Limit