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🧪 Pharmaceutical QC Calculation Tool

Dissolution Calculator

Professional dissolution test calculator for pharmaceutical tablets and capsules. Enter the response value for each dissolution vessel/unit at a single time point or across a full multi time-point profile, and instantly get the individual % drug release, mean, standard deviation, and %RSD — checked against USP <711> Q-value acceptance criteria with Stage 1 / Stage 2 / Stage 3 logic. Supports HPLC peak area or UV-Vis absorbance data, with a full step-by-step math log. No manual calculation needed.

🔬 HPLC / UV-Vis 🧪 Dissolution Test (% Release) ⏱️ Single & Multi Time-Point 📊 Mean, SD & %RSD ✅ USP <711> Stage 1/2/3
1
Select instrument & test mode
Single or Multi Time-Point
2
Enter standard data
and Q-value criteria
3
Add each vessel/unit
response per time point
4
Get mean, %RSD &
Stage pass/fail with math log
Acceptance Criteria: 📊 Stage 1 (S1): n=6, each unit ≥ Q+5% 📈 Stage 2 (S2): n=12, mean ≥ Q, no unit < Q−15% 📈 Stage 3 (S3): n=24, mean ≥ Q, criteria per USP <711>
Dissolution Calculator 📘 Concept & Beginner Guide

Dissolution Test Data Entry

💡
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
Dissolution Formula
% Result = (Area/Abs of Spl × Dilution Factor × Std Potency × Standard Weight × 100) ÷ (Area/Abs of Std × Label Claim × 100)

or, with optional API Factor:

% Result = (Area/Abs of Spl × Dilution Factor × Std Potency × Standard Weight × Factor × 100) ÷ (Area/Abs of Std × Label Claim × 100)
Dissolution method: Use this to assess the rate and extent of drug release from a tablet or capsule. Each vessel/unit is sampled and analyzed independently. The batch passes a given stage only if every unit's % release meets the Q-value criterion for that stage (or the stage-specific mean/individual logic per USP <711>).
Test Mode
🎯
Single Time-Point
One dissolution time point only (e.g. Q at 30 minutes). Use this when your method specifies a single sampling time.
📈
Multi Time-Point Profile
Several dissolution time points (e.g. 10, 20, 30, 45, 60 min) to build a full release profile. Add as many time points as your protocol requires.
System Configuration & Constants
Select the instrument used for analysis
Selected: HPLC (Peak Area)
From your balance record (e.g. 20.0)
From your standard CoA (e.g. 100.0)
The combined dilution factor for both the standard and sample preparations used in this calculation (as per SOP).
Total volume of dissolution medium per vessel (e.g. 900 mL). For documentation/report purposes only — not used in the % Release formula. Dilution Factor already accounts for medium volume per your SOP.
API content stated on the product label per dosage unit (e.g. 500.0)
Only fill if your method requires an API correction factor
Acceptance criterion from your dissolution monograph/spec (e.g. Q = 80.0%)
Common informational limit (verify against your own SOP)
Standard System Suitability
Covering Standard is OFF — only the System Suitability readings above are used for every time point.
Standard Injections: Count = 0 | Mean = 0.00 | SD = 0.00 | % RSD = 0.00%
Dissolution Time Points & Vessel Readings
Dissolution Verification Successful
Calculated parameters match operational target criteria bounds.
🧪 System Suitability: Standard Injections: Count = 0 | Mean = 0.00 | SD = 0.00 | % RSD = 0.00%

Step-by-Step Calculation Trace — Selected Time Point

1
Step 1 — Standard Summary
Summary of standard injection values and system suitability check:
2
Step 2 — Dissolution Formula with Values
The dissolution formula with your actual numbers substituted in:
3
Step 3 — Per-Vessel Intermediate Values
Calculated intermediate values and each vessel's result:
4
Step 4 — Final Dissolution Result
Final mean % release, SD, %RSD and min/max range:

Simplified Step-by-Step Summary

1
Step 1: Standard Mean & %RSD
Calculate mean and %RSD of your standard injections to verify system suitability.
2
Step 2: Vessels Processed
Count the number of valid vessel/unit readings used in the calculation.
3
Step 3: Apply Dilution, Purity & Factor
Apply dilution factor and purity correction to calculate each vessel's % release.
4
Step 4: Final Mean % Release & %RSD
Average all vessel % release values and calculate %RSD to get the final dissolution verdict.
⚠️ Disclaimer
BestPharmaTools.com provides this Dissolution 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.