Does an F2 Similarity Value of 50 Mean the Two Dissolution Profiles are Only 50% Similar?

No, the similarity factor (F2) is a mathematical representation of the quadratic mean difference between two dissolution profiles across all considered time points. An F2 value of 50 indicates that the two profiles differ by a small margin, with a mean difference of approximately 10%.

The similarity factor is not a linear indicator:

  • An F2 value of 100 represents a 0% mean difference.
  • An F2 value of 50 corresponds to about a 10% mean difference.
  • However, an F2 value of 75 does not correspond to a 5% mean difference. Instead, it indicates a mean difference of approximately 3%.
    The F2 equation is specifically designed to be more sensitive to differences when those differences are below 10% for better discrimination.

Simply instead of F2 equation, the Quadratic mean of the difference in %dissolved over the considered time point may be calculated and the two profile considered similar if the results is less than 9.95.


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Resource Person: Abd El-Rahman Sayed

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