Accelerated Stability Assessment Program (ASAP) - American ...

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Effect of Activation Energies on Shelf Life(Constant RH)Shelf-Life (years)E a(kcal/mol) 25C 30C 40C12 Low activation energy 5.0 3.6 1.929 Average activation energy 5.0 2.2 0.539 High activation energy 5.0 1.7 0.214
<strong>ASAP</strong> Screening-Protocol: Set to GenerateSpecification Levels GenericallyProtocol T (C) %RH Days50 75 1460 40 14Drug Product70 5 14<strong>Stability</strong> Screen70 75 180 40 2Actual protocol is product-specific!15
Page 1 and 2: Accelerated Stability AssessmentPro
Page 3 and 4: Accelerated Stability AssessmentPro
Page 5 and 6: log kExcipient/API Interactions-0.6
Page 7 and 8: Stability at Different Temperatures
Page 9 and 10: 80CArrhenius Plot:Two Approaches70C
Page 11 and 12: Aspirin Tablet Degradation70C50C 40
Page 13: Effect of B Values on Shelf Life (C
Page 17 and 18: Error Bars for Predicted Shelf-Life
Page 19 and 20: Error Bars for Predicted Shelf-Life
Page 21 and 22: Protocol ExampleFinal protocol may
Page 23 and 24: Protocol ExampleFinal protocol may
Page 25 and 26: Packaged-Product StabilityH 2 OH 2
Page 27 and 28: %H 2 OMoisture Sorption Isotherm—
Page 29 and 30: Moisture Vapor Transmission Rateper
Page 31 and 32: %RHEmpty Bottle/Blister Equilibrati
Page 33 and 34: %RHPredicted (Lines) vs. Measured R
Page 35 and 36: Example 2: More Stable Drug Product
Page 37 and 38: Bridging Science and Regulations•
Page 39 and 40: Acknowledgments• Pfizer scientist

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