Dissolution Profile Similarity (f₂) Calculator
- Purpose: This calculator evaluates similarity between Test Product and Reference Product dissolution profiles using f₂ (Similarity Factor) and f₁ (Difference Factor) as per regulatory requirements.
- Enter Optional Sections details:
- Product Detail: For documentation and reporting.
- Dissolution Method Detail: To capture experimental conditions.
- Enter Dissolution Profile Data:
- Provide Time Points (min) (excluding 0).
- Enter Reference (prechange) Product (% drug dissolved).
- Enter Test (postchange) Product (% drug dissolved).
- A minimum of three (03) common time points (excluding zero) is required for calculation.
- Click Calculate to compute f₂ and f₁ values with interpretation.
- Click Show Detailed Calculation to review step-by-step calculations.
- Use Print / Save as PDF to generate a report. Always review the printed report for correctness before use.
-
Methodology & Conditions
- Model-Independent: Profiles are compared directly at each time point without kinetic modeling.
- Identical Conditions: Test and Reference must share the same apparatus, medium, agitation speed, and temperature.
- Sampling Time Points: Must be identical for both (e.g., 5, 10, 15, 30, 45, 60 min) and cover the full profile including early, intermediate, and later stages of dissolution.
- Plateau Condition: If 85% dissolution is not reached, include time points until a plateau (asymptotic release) is observed.
- Continuity: Do not skip intermediate time points between selected sampling intervals.
- Early Sampling: For rapidly dissolving products, where complete dissolution is within 30 minutes, generation of an adequate profile by sampling at 5- or 10-minute intervals may be necessary.
-
Data Requirements
- Sample Size: Mean data from twelve (12) dosage units per time point for each formulation.
- Minimum Data: At least 3 time points (excluding zero) are required.
- Variability Criteria: % RSD (relative standard deviation) / % CV (coefficient of variation) must not exceed 20% at the first/earlier time point and 10% at all subsequent time points.
-
Evaluation & Constraints
- The 85% Rule: Only one time point is included after ≥85% dissolution for any of the formulations; subsequent points are excluded automatically.
- Very Rapid Dissolution: If Test & Reference products both reach ≥85% dissolution in ≤15 min, the profiles may be considered similar without further mathematical evaluation.
- Similarity factor (f₂): values should be close to 100 and f₂ ≥ 50 (range 50–100) indicates similarity between profiles.
- Difference factor (f₁): values should be close to 0 and f₁ ≤ 15 (range 0–15) indicates acceptable difference.
-
Applicability
- Applicable to oral solid dosage forms (e.g., tablets and capsules).
- Suitable for Immediate Release (IR) and Modified Release (MR) formulations.
📖 How to Use Calculator
⚖️ Important Notes
Product Detail (Optional)
Dissolution Method Detail (Optional)
Dissolution Profile Data
| Time (min) | Reference Product (mean % drug dissolved) | Test Product (mean % drug dissolved) |
|---|
Disclaimer: The results provided by this calculator are for general informational purposes only.
Users are responsible for verifying all calculations and ensuring suitability for their own formulation, manufacturing, or regulatory needs.
Cakk Magg X Pharmaceutical Services makes no warranties regarding accuracy or applicability and disclaims any liability for use or reliance on the results.
Explore More Calculators: Access additional pharmaceutical calculators designed to support formulation development, batch planning, and manufacturing operations. Use the button below to navigate to the Pharmaceutical Calculators page.