How to use the F1 and F2 Dissolution Calculator Excel Tool
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.
Related article: Dissolution Profile Comparison: F1 & F2 Calculation in Excel
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F1 and F2 Dissolution Calculator Preview
Frequently Asked Questions
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The f2 dissolution calculator is a tool used to compare dissolution profiles between a test product and a reference product by calculating the:
f1 difference factor
f2 similarity factor
These calculations help determine whether two formulations have similar drug release characteristics.
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f1 and f2 calculations are important because they help evaluate whether two drug products have comparable dissolution behavior, which may indicate similar bioavailability and therapeutic performance.
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The f1 factor, also called the difference factor, measures the percentage difference between two dissolution curves at each time point. Lower f1 values indicate greater similarity between profiles.
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The f2 factor, also known as the similarity factor, measures how similar two dissolution profiles are. Higher f2 values indicate greater similarity between the test and reference products.
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Dissolution profiles are generally considered similar when:
0≤f1≤15
and
50≤f2≤100
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FDA guidance recommends using at least:
n≥3 time points
for meaningful dissolution profile comparison.
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The calculator can automatically calculate the mean and relative standard deviation (RSD) for up to:
12 replicates
at each dissolution time point.
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