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

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Typical E a and B values (n=60)29.80.043RH sensitivity does not indicate hydrolysis!12
Effect of B Values on Shelf Life (Constant T)B0.00low moisturesensitivity0.04average moisturesensitivity0.09high moisturesensitivity60%RH inPVCBlister65%RH inPVCBlister75%RH inPVCBlister60%RH inBottle +Desiccant5.0 yrs 5.0 yrs 5.0 yrs 5.0 yrs5.0 yrs 3.8 yrs 2.6 yrs 7.1 yrs5.0 yrs 3.0 yrs 1.2 yrs 8.8 yrs13
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: Aspirin Tablet Degradation70C50C 40
Page 15 and 16: ASAP Screening-Protocol: Set to Gen
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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