Dissolution % Released Calculator (UV or HPLC, Volume Correction)
% of label claim dissolved per vessel and time, with the volume correction and stages.
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About the Dissolution % Released Calculator (UV or HPLC, Volume Correction)
Turns the absorbances or peak areas of a dissolution test into the % of the label claim dissolved in every vessel at every time point: against one standard (weighed or of known concentration) or a calibration line, with the sample dilution and the correction for the samples withdrawn — with the medium replaced or not — then the mean, SD and RSD, the profile chart and the acceptance stages of the harmonised dissolution chapter: S1 to S3 for immediate release, L1 to L3 for extended release, and the acid and buffer stages of delayed release.
Paste the readings straight from the spectrophotometer or the data system, one row per vessel, and get the verdict with every criterion, ready for the batch record. Without a pass the result is a free preview: the stage the test conforms at (or the next step) and each criterion; the percentages, the statistics, the chart, the PDF and Excel report and printing unlock with a Premium pass.
How to use it
- Choose UV or HPLC and how the result is calibrated: one standard (its readings, and its weight, purity, volume and dilution — or its concentration) or a calibration line (slope and intercept, or the standards to fit it).
- Enter the label claim, the medium volume, the volume withdrawn at each time point and whether it is replaced with fresh medium, and the sample dilution.
- Enter the time points, in minutes or (for extended release, as monographs give them) in hours, and paste the readings: one row per vessel, one column per time point (a header row is skipped), or one row per time point.
- Choose the acceptance: Q and its time point for immediate release or the buffer stage, the acid-stage time, or the ranges for extended release. Press Calculate % released; without a pass the result stays a free preview with the figures hidden, and the PDF, the Excel workbook and printing unlock with a pass.
Examples
Absorbance 0.4650; standard 0.5505 at 55.43 µg/mL; sample diluted 10 times
0.4650 ÷ 0.5505 × 55.43 × 10 = 468.2 µg/mL
900 mL of medium, 10 mL withdrawn and replaced each time; 0.215, 0.334 and 0.412 mg/mL at the first three samples, 0.468 mg/mL at the fourth
Amount at the fourth sample = 0.468 × 900 + 10 × (0.215 + 0.334 + 0.412) = 430.8 mg
Without replacement the medium left at the fourth sample is 900 − 3 × 10 = 870 mL.
Six units at 30 min: 86.3, 85.1, 87.7, 85.6, 86.9 and 84.9 %
Rounded to the decimals of Q, each is at least Q + 5 % = 85 %: conforms at S1 (84.9 rounds to 85)
Common uses
- A QC analyst working out a dissolution run of 6, 12 or 24 tablets or capsules and its stage.
- Profiles for development batches and comparisons, with the mean, RSD and chart per time point.
- Checking a spreadsheet’s volume-replacement correction before a result is reported.
How the % released is worked out
- Concentration = reading ÷ mean reading of the standard × concentration of the standard × sample dilution; with a calibration line, (reading − intercept) ÷ slope. A weighed standard is weight × purity ÷ 100 ÷ volume ÷ dilution.
- Amount dissolved, with v mL withdrawn at each time point and V mL of medium: medium replaced, concentration × V + v × the sum of the concentrations of the earlier samples; medium not replaced, concentration × (V − the samples already taken) + v × the sum of the earlier concentrations; or no correction.
- % dissolved = amount ÷ label claim × 100, then the mean, the sample standard deviation and the RSD of the vessels at each time point.
The harmonised chapter asks for the withdrawn aliquots to be replaced with fresh medium at 37 °C, or, where replacement is shown to be unnecessary, for the volume change to be corrected in the calculation.
The acceptance tables
- Immediate release (S1–S3): S1, 6 units, each not less than Q + 5 %; S2, 6 more, the mean of 12 not less than Q and no unit below Q − 15 %; S3, 12 more, the mean of 24 not less than Q, not more than 2 units below Q − 15 % and none below Q − 25 %. Testing continues through the stages unless the results conform at S1 or S2.
- Extended release (L1–L3): L1, no unit outside any of the stated ranges and none below the stated amount at the final time; L2, the mean of 12 within each range and not below the final amount, no unit more than 10 % of the label outside a range or below the final amount; L3, the mean of 24 likewise, not more than 2 of 24 units more than 10 % outside or below, and none more than 20 %.
- Delayed release: acid stage A1, no unit above 10 % dissolved; A2 and A3, the mean of 12 or 24 not more than 10 % and no unit above 25 %. Buffer stage B1–B3 as S1–S3 with the Q of the buffer stage.
Q, the times and the ranges come from the monograph or the approved specification. Values and means are compared after rounding to the decimals of the limit, unless you choose unrounded comparison.
Sources
- Japanese Pharmacopoeia, English edition: General Tests, 6.10 Dissolution Test — the harmonised text, with the acceptance tables 6.10-1 to 6.10-4 and the sampling note
- PMDA: the Japanese Pharmacopoeia in English — the edition and its supplements
- PMDA: pharmacopoeial harmonisation — how the chapter is harmonised with the European Pharmacopoeia and the United States Pharmacopeia
Limitations
- It calculates from the readings you enter: it does not run or validate the analytical method, or check the apparatus.
- The same volume is assumed withdrawn at every time point; for different volumes, run the calculation per time point.
- Interpretation 2 of the Japanese Pharmacopoeia (no Q in the monograph) and other local rules are not covered.
- MySmartCoPilot is not affiliated with or endorsed by any pharmacopoeia or regulator; the chapter is cited for its published acceptance tables.
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Frequently asked questions
What do I get without a pass?
Without a pass, Dissolution % Released Calculator (UV or HPLC, Volume Correction) shows the method, the limits that apply and the verdict for your input; computed figures stay hidden until the result is unlocked. Until you unlock it, the result can’t be downloaded or printed. A Premium or Ultimate pass, a one-time payment that never renews, unlocks the full result. The pricing page lists the passes and their prices.
What does the free preview show?
The stage the test conforms at, or the next step, with every criterion and whether it is met, the method and the limits that apply. The % released of each vessel, the statistics, the amounts and the profile chart show as “•••” or locked; the PDF report, the Excel workbook and printing unlock with a Premium pass.
Do I need the volume correction if I replace the medium?
Yes, for the drug taken away in the earlier samples: each withdrawn aliquot carried some dissolved drug, so the amount at a time point is the concentration × the medium volume plus the volume withdrawn × the sum of the earlier concentrations. Without replacement the medium left also shrinks with each sample.
How many units do I enter?
The units tested: 6 for stage 1, 12 for stage 2 and 24 for stage 3. With 12 units entered, stage 1 is judged on the first 6 and stage 2 on all 12, as the stages are run.
How do I enter extended-release ranges?
One line per time point: the time, then the lowest and the highest % allowed — for example “60 20 40” for 20–40 % at 60 min — and for the final time only the lowest, such as “480 80” for not less than 80 %. With the time unit set to hours the same specification is “1 20 40” and “8 80”.
Are the values rounded before they are compared?
By default each value and mean is rounded to the decimals of Q or of the range (85 % with Q = 80 %, so 84.9 % counts as 85 %). Choose unrounded comparison if your procedure says so.