F1 & F2 Dissolution Profile Comparison

Organization

Product

Label Claim (mg)

Reference Batch No.

Test Batch No.

Dissolution Information:

No of Time Points

No of Units

Dissolution Data:

Time Point Selection for F1/F2 Calculations: Check/uncheck time points to include/exclude from F1/F2 calculations

Dissolution Profile: Reference

Dissolution Profile: Test

F1 & F2 Calculation Results:

Difference Factor (f₁)

Acceptance: 0-15

Similarity Factor (f₂)

Acceptance: 50-100

Guidance Limit (%)

Points >85% excluded from calculation

Validation Checks:

Enter data to see validation results

Dissolution Profile Visualization:

Drug Release Profile Comparison

F1 & F2 Values Trend

Sample Data:

Calculation Formulas:

F1: f₁ = {[Σ|Rt - Tt|] / [Σ Rt]} × 100

F2: f₂ = 50 × log{[1 + (1/n)Σ(Rt - Tt)²]⁻⁰·⁵} × 100

Legend:

Rt: Mean dissolution value of reference batch at time t (shown in Reference table)

Tt: Mean dissolution value of test batch at time t (shown in Test table)

n: Number of time points included in calculation

RSD: Relative Standard Deviation using sample SD (n-1) - pharmaceutical standard