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

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Likely Causes for Poor Fit/PredictionForm/Phase change caused by T/RH: melts, glass transitions,anhydrate/hydrate formationln k80/4070/75%RH60/4050/7540/7530/75Ln A30/6525/6070/5BE a /R1/T20
Protocol ExampleFinal protocol may require several iterations!T (C) %RH Days % Degradant50 75 14 0.450.0560 40 14 0.240.0270 5 14 0.090.0270 75 1 0.680.07SpecificationLimit = 0.2%80 40 2 0.590.0625C/60%RH shelf-life (PVC blister)25C/60%RH shelf-life (HDPE bottle)30C/65%RH shelf-life (HDPE bottle)30C/65%RH shelf-life (HDPE bottle, desiccant)2.4-13.2 yrs4.2-18.8 yrs1.8-5.6 yrs3.5-8.8 yrs21
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 and 14: Effect of B Values on Shelf Life (C
Page 15 and 16: ASAP Screening-Protocol: Set to Gen
Page 17 and 18: Error Bars for Predicted Shelf-Life
Page 19: Error Bars for Predicted Shelf-Life
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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