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Dissolution testing has become an essential tool in the pharmaceutical industry at various stages of development, manufacturing and marketing.For the comparison of dissolution profiles, similarity factor f 2 is gaining popularity due to its recommendation by various regulatory committees.Dissolution profiles are considered similar if the calculated f 2 value is between 50 and 100.In our opinion,this acceptance limit might not be correctly defined.This article presents the reasons for the same and a new equation to define the lower acceptance limit for different data sets.It is proposed that regulatory agencies should actively consider the revision of the lower acceptance value for f 2 .dx.
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Gohel et al. (2002) studied this question.
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