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Comparative Dissolution Profile (CDP) Calculator

Run a single Reference or Test product dissolution profile, or compare Reference vs Test side-by-side across multiple time points — with automatic % Result, mean, SD, %RSD per time point, and f2 similarity factor calculation per FDA/EMA guidance.

1
Pick Compare, Test-only
or Reference-only mode
›
2
Enter Standard readings,
weight, potency & DF
›
3
Add time points and
each unit's area/absorbance
›
4
Get % Result, mean, SD,
%RSD and f2 automatically
›
5
Copy the complete
QC report
🧮 Calculator 📘 Concept & Beginner Guide
🧭 Step 1

What Would You Like to Calculate?

✓
🆚
Comparative (Reference vs Test)
You have both Reference and Test data and want a side-by-side comparison with the f2 similarity factor.
✓
🔵
Test Product — Already Tested (Refrence Product)
You've already run the Reference product. Now work out the Test product's dissolution profile so both can be compared for the f2 similarity factor.
✓
🟣
Reference Product — Already Tested (Test Product)
You've already run the Test product. Now work out the Reference product's dissolution profile so both can be compared for the f2 similarity factor.
⚙️ Step 2

Standard Configuration & System Suitability

💡
Missing Dilution Factor?
If you do not know how to determine the Standard or Sample Dilution Factor, you can easily calculate it using our standalone Dilution Factor Calculator Tool on the homepage.
🧮 Go to Dilution Calculator
% Result Formula
% Result = (Area/Abs of Spl × Dilution Factor × Std Potency × 100) ÷ (Area/Abs of Std × Label Claim × 100)

% Result (with Factor) = (Area/Abs of Spl × Dilution Factor × Std Potency × Factor × 100) ÷ (Area/Abs of Std × Label Claim × 100)
Data
All field labels update automatically with this selection
Applies everywhere — Standard Readings, Covering Standard, % Result, time-point tables, f₂, and the printed report
Dilution Factor as per your CDP protocol
From the standard's Certificate of Analysis
Strength of active ingredient per dosage unit as stated on the product label
Leave blank if not applicable
🧪 Step 3

Time Points — Reference vs Test

Each block below is one dissolution time point. Enter the Area/Absorbance for each of the 12 units under Reference Product and Test Product — % Result, mean, min/max, SD and %RSD are calculated automatically for each side.

📐
Comparative Profile Calculated
Review the comparative table and f2 similarity factor below.
📋
f2 Acceptance Criteria — Regulatory Reference
ICH M9 (2018) & FDA Guidance for Industry — Dissolution Testing of IR Solid Oral Dosage Forms (1997)
⏱️ Before 15 min
Early time points (e.g. 5, 10 min): %RSD (coefficient of variation) should not exceed 20% for mean data to be used.
✅ At 15 min
If both Reference and Test reach ≥85% dissolved, the profiles are automatically considered similar — f2 is not required. This row is highlighted below when it applies.
⏱️ After 15 min
All later time points: %RSD should not exceed 10% for mean data to be used in the f2 calculation.
  • A minimum of 3 time points is required (the zero/pre-dose point is excluded).
  • Time points must be the same for Reference and Test.
  • Each mean should be derived from 12 individual dosage units per product, per time point.
  • Not more than one mean value ≥85% dissolved may be used, per product, in the f2 calculation.
  • Two profiles are considered similar when f2 ≥ 50.
Note on the 20% CV window: ICH M9 defines "early time points" as up to 10 minutes; the FDA's 1997 dissolution guidance uses 15 minutes as its own worked example of an early time point. Both agree the ceiling is 20% CV early and 10% CV afterward — confirm which cut-off your SOP/monograph specifies.
📊 Comparative Summary

Reference vs Test — % Result by Time Point

Time Point
(min)		 % Result Calculation
Reference Product (Rt) Test Product (Tt) (Rt − Tt) (Rt − Tt)²
f2 Similarity Factor
f2 = 50 × log [100 / √(1 + Σ(Rt − Tt)² / n)]
—
Awaiting data
Time Points Compared
0
Number of time points used in f2 calculation
f2 Similarity Factor
—
Similar if f2 is between 50 and 100
Sum of (Rt − Tt)²
0.00
Across all compared time points
🧮 Calculation Breakdown

f2 Similarity Factor — Step-by-Step Math Log

1
Sum of (Rt − Tt)²
Sum of the squared differences between Reference and Test % Result across all compared time points.
—
2
Sum (Rt − Tt)² / n
Divide the sum of squared differences by the number of time points (n).
—
3
1 + Sum(Rt − Tt)² / n, then √
Add 1, then take the square root of the result.
—
4
f2 = 50 × log [100 / √(...)]
Final f2 similarity factor calculation.
—
⚠️ Disclaimer
BestPharmaTools.com provides this Comparative Dissolution Profile (CDP) Calculator strictly for educational and informational purposes. It is an independent, unaffiliated online tool and is not a validated laboratory instrument, controlled GMP document, or a substitute for your organization's approved Quality Management System, Standard Operating Procedures, or review by qualified QA/QC personnel. All data entered is provided solely by the user; BestPharmaTools.com does not verify, endorse, or take responsibility for its accuracy, completeness, or suitability for any regulatory, clinical, or commercial use. Any output — including results viewed, copied, or printed — is used entirely at the user's own discretion and risk. BestPharmaTools.com and its owners/affiliates accept no liability for any decisions, actions, losses, or damages arising from use of this tool. Always verify calculations independently and follow your organization's validated systems and approved SOPs for any official, regulatory, or GMP-related documentation.
🧪 Step 3

Time Points — Test Product

Each block below is one dissolution time point for the Test product. Enter Area/Absorbance for each of the 12 units — % Result, mean, min/max, SD and %RSD are calculated automatically.

🔵
Test Product Dissolution Profile
Review the % Result by time point below.
📈 Graphical Presentation

Test Product — Dissolution Profile Chart

📊 Profile Summary

Test Product — % Result by Time Point

Time Point (min)% Result (Mean)Min %Max %SD%RSD
⚠️ Disclaimer
BestPharmaTools.com provides this Comparative Dissolution Profile (CDP) Calculator strictly for educational and informational purposes. It is an independent, unaffiliated online tool and is not a validated laboratory instrument, controlled GMP document, or a substitute for your organization's approved Quality Management System, Standard Operating Procedures, or review by qualified QA/QC personnel. All data entered is provided solely by the user; BestPharmaTools.com does not verify, endorse, or take responsibility for its accuracy, completeness, or suitability for any regulatory, clinical, or commercial use. Any output — including results viewed, copied, or printed — is used entirely at the user's own discretion and risk. BestPharmaTools.com and its owners/affiliates accept no liability for any decisions, actions, losses, or damages arising from use of this tool. Always verify calculations independently and follow your organization's validated systems and approved SOPs for any official, regulatory, or GMP-related documentation.
📐 Optional

Get Your f2 Similarity Factor

You've calculated the Test Product profile above. To get a proper f2 similarity factor, enter the matching Reference Product % Result for each time point — the time point and Test value are pre-filled from your data above, and every cell is editable. Click "Calculate" to fill in the (Rt − Tt) and (Rt − Tt)² columns and get your f2.

Time Point
(min)		 % Result Calculation
Reference Product (Rt) Test Product (Tt) (Rt − Tt) (Rt − Tt)²
🧪 Step 3

Time Points — Reference Product

Each block below is one dissolution time point for the Reference product. Enter Area/Absorbance for each of the 12 units — % Result, mean, min/max, SD and %RSD are calculated automatically.

🟣
Reference Product Dissolution Profile
Review the % Result by time point below.
📈 Graphical Presentation

Reference Product — Dissolution Profile Chart

📊 Profile Summary

Reference Product — % Result by Time Point

Time Point (min)% Result (Mean)Min %Max %SD%RSD
⚠️ Disclaimer
BestPharmaTools.com provides this Comparative Dissolution Profile (CDP) Calculator strictly for educational and informational purposes. It is an independent, unaffiliated online tool and is not a validated laboratory instrument, controlled GMP document, or a substitute for your organization's approved Quality Management System, Standard Operating Procedures, or review by qualified QA/QC personnel. All data entered is provided solely by the user; BestPharmaTools.com does not verify, endorse, or take responsibility for its accuracy, completeness, or suitability for any regulatory, clinical, or commercial use. Any output — including results viewed, copied, or printed — is used entirely at the user's own discretion and risk. BestPharmaTools.com and its owners/affiliates accept no liability for any decisions, actions, losses, or damages arising from use of this tool. Always verify calculations independently and follow your organization's validated systems and approved SOPs for any official, regulatory, or GMP-related documentation.
📐 Optional

Get Your f2 Similarity Factor

You've calculated the Reference Product profile above. To get a proper f2 similarity factor, enter the matching Test Product % Result for each time point — the time point and Reference value are pre-filled from your data above, and every cell is editable. Click "Calculate" to fill in the (Rt − Tt) and (Rt − Tt)² columns and get your f2.

Time Point
(min)		 % Result Calculation
Reference Product (Rt) Test Product (Tt) (Rt − Tt) (Rt − Tt)²