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1.4
1.2
 
    
  
%Degradant

1
0.8
0.6
0.4
0.2
0
0 10 20 30 40 50 60
Relative Time

 
     
 
 
 
  

 
 
 
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ASAP: Accelerated Stability Assessment
Program (Isoconversion)
      

 



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2

1 Predicted Shelf Life


0 (traditional approach) 0.5 yrs
-1
Experimental Shelf Life 1.2 yrs
-2
ln(k)

-3

-4
   
  

   
-5
 
-6
  

-7

-8
0.002850.002900.002950.003000.003050.003100.003150.003200.003250.003300.003350.00340
1/T (K)

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ln(k)

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0.00280 0.00290 0.00300 0.00310 0.00320 0.00330 0.00340
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Humidity Corrected Arrhenius Equation

     

ln k = ln A - Ea/(RT) + B(%RH)

   
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Typical Ea and B values (n=60)






    
  
 



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4°-Structure
• Subunits dissociated
• Subunits disrupted
3°-Structure
• Covalent interactions disrupted
between amino acid side chains
• Dipole-dipole interactions between
amino acid side-chains with
themselves and solvent disrupted
• Van der Waals interactions
disrupted between nonpolar
amino acid side-chains
2°-Structure
• loss of repeat patterns (-helices,
-sheets)
1°-Structure
• Not impacted

     
 
 
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