Dissolution Calculator — Quick Concept & Beginner Guide
📘 Quick Concept
What is a Dissolution Test and How Does This Calculator Work?
🧪
What is a Dissolution Test?
A dissolution test measures how much active pharmaceutical ingredient (API) is released from a tablet or capsule into a dissolution medium over time. A set of vessels (units) — typically 6, then 12, then 24 per USP stages — are tested simultaneously. At each time point, an aliquot is withdrawn from every vessel and analyzed by HPLC or UV-Vis. The result for each vessel is reported as a % of the labelled drug content released, and this is compared against the Q-value acceptance criterion defined in the dissolution monograph or specification.
⚖️
When is Dissolution Testing Performed?
Dissolution testing is performed during routine batch release, stability studies, and product development to confirm that the dosage form releases its drug content at the expected rate. It is a critical quality attribute under cGMP and is required by USP <711> / <2040>, ICH, and FDA guidance. If Stage 1 (6 units) does not meet the Q-value criterion, testing proceeds to Stage 2 (12 units) and, if needed, Stage 3 (24 units), each with progressively defined acceptance logic.
💡 Beginner Tip
Beginner Tips — How to Fill the Form
- Test Mode: Choose Single Time-Point if your method specifies one dissolution time (e.g. Q at 30 min), or Multi Time-Point if you are building a full dissolution profile across several time points (e.g. 10, 20, 30, 45, 60 min).
- Standard Weight (mg): Enter the accurately weighed mass of your reference standard from the balance record.
- Standard Potency / Purity (%): Check your reference standard certificate of analysis (CoA) for this value. Example: 100.0%
- Dilution Factor: One combined dilution factor from your dissolution sample preparation SOP (e.g. 1, if the withdrawn aliquot is analyzed directly without further dilution).
- Dissolution Medium Volume (mL): The total volume of dissolution medium in each vessel, per your method (e.g. 900 mL).
- Label Claim (mg per unit): The API content stated on the product label, per tablet or per capsule.
- Q-Value (%): The acceptance criterion from your dissolution monograph/specification (e.g. Q = 80% means not less than 80% of labelled content must dissolve).
- Time Points: In Multi Time-Point mode, add a tab for every time point in your protocol (e.g. 10, 20, 30, 45, 60 min) — each tab has its own set of vessel readings.
- Vessel / Unit Rows: Add one row per dissolution vessel/unit (typically start with 6 for Stage 1). Enter the response (peak area or absorbance) for each.
- Result: Each vessel gets its own % release; the calculator reports the mean, standard deviation, %RSD, and Stage 1/2/3 pass/fail verdict against your Q-value.