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F2 parameter is widely used parameter in drug dissolution testings where it is often used to predict similarity of two dissolution profiles. F2 factor

In short, two profiles are considered identical when f2=100. An average difference of 10% at all measured time points results in a f2 value of 50. A public standard of f2 value between 50-100 to indicate similarity between two dissolution profiles. That means if difference at each sampling time is 10% or less then f2 value will be between 50 and 100. Therefore, a quick way to establish similarly of two profiles is to see if differences in dissolution results at each sampling time are less than 10%.

The presentation below depicts concise information regarding f2 analysis and variabilities that occur, and the standards used by different guidelines and drug authorities.

F2 factor

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