Accelerated Stability Assessment Program (ASAP) - American ...
Accelerated Stability Assessment Program (ASAP) - American ... Accelerated Stability Assessment Program (ASAP) - American ...
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12.07.2015
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%RHBottle/Blister Equilibration with Tablets605550454035300 2 4 6 8 10years25ºC/60%RH Oven60 500-mg tablets 2:1 MCC:lactose60-cc bottle + 60 tabletsAclar blister + 1 tablet32
%RHPredicted (Lines) vs. Measured RH706050empty bottle2 tablets40302010015 tablets15 tablets + desiccant0 10 20 30 40 50 60 70Days500 mg tablets of CP-48171560-cc HDPE Bottles (40C/75%RH)33
- 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 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: %RHEmpty Bottle/Blister Equilibrati
- 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
%RHBottle/Blister Equilibration with Tablets605550454035300 2 4 6 8 10years25ºC/60%RH Oven60 500-mg tablets 2:1 MCC:lactose60-cc bottle + 60 tabletsAclar blister + 1 tablet32
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