💊 Dissolution Profile Comparison
Dissolution f2 Similarity Calculator
Compare dissolution profiles of reference and test products using the f2 similarity factor and f1 difference factor, as recommended by FDA (1997) and EMA CPMP guidance. Enter % dissolved at each time point.
Time-Point Data
| Time (min) | Reference (%) | Test (%) | Diff² |
|---|
f2 Formula (FDA/EMA):
f2 = 50 × log₁₀{ 100 / √[ 1 + (1/n) × Σ(Rt − Tt)² ] }
Source: FDA Dissolution Testing of Immediate Release Solid Oral Dosage Forms (1997); EMA CPMP/EWP/QWP/1401/98
f2 = 50 × log₁₀{ 100 / √[ 1 + (1/n) × Σ(Rt − Tt)² ] }
Source: FDA Dissolution Testing of Immediate Release Solid Oral Dosage Forms (1997); EMA CPMP/EWP/QWP/1401/98
ℹ️ FDA Requirements: Only one time point after 85% dissolution of reference. Coefficient of variation ≤ 20% at early points, ≤ 10% at later points. At least 3 time points required.
Results
Enter time-point data to calculate f1 and f2
Regulatory Context: f2 ≥ 50 indicates similarity between test and reference profiles (FDA/EMA). f1 ≤ 15 indicates acceptable difference. If f2 < 50, the profiles are considered dissimilar and may require a bioequivalence study.