How to use the F1 and F2 dissolution calculator
In dissolution testing, f1 difference and f2 similarity calculations are used to compare formulations with one another or with a reference batch. The calculator shown below can quickly calculate values for f1 and f2. By utilizing this tool, scientists can significantly reduce the time required for calculations.
Simply enter your dissolution data in the yellow input area as shown below and that’s it! You will get the f1 and f2 values immediately.
The model automatically calculates the mean and relative standard deviation (RSD) at each time point for up to 12 replicates.
The calculator considers the following points from FDA guidance on similarity calculations for dissolution:
The formula is most suitable for dissolution profile comparison when three or more dissolution time points are available
Only one measurement should be considered after 85% dissolution of both products
Only one value greater than 85% is considered in the calculation. The numbers under Rt and Tt are the final values used in the calculation.
To allow use of mean data, the RSD at the earlier time points (<15 min) should not be more than 20% and at other time points it should not me more than 10%
Any RSD value that exceeds 10% will be flagged and shown in red font.
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