Calculate the similarity factor (f₂) between a Reference and a Test dissolution profile. An f₂ value between 50 and 100 suggests that the two dissolution profiles are similar.
Time Point (min)
Reference % Dissolved (Rt)
Test % Dissolved (Tt)
Action
Calculation Results
Similarity Factor (f₂)
FDA Guidance Rules for f₂ Calculation:
A minimum of three time points (zero excluded) should be used.
The time points should be the same for both the reference and test profiles.
Not more than one mean value of > 85% dissolved for any of the formulations should be included in the calculation.
The relative standard deviation (RSD) of the mean of any product should be less than 20% for the early time points and less than 10% from other time points.