Dissolution Acceptance Stage Checker (S, L, A and B Stages)
S1 to S3, L1 to L3 and the acid and buffer stages for every batch, with the criteria met.
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- Free preview: the method, the limits that apply and the verdict for your input; computed figures stay hidden until the pass.
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Stage verdicts
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About the Dissolution Acceptance Stage Checker (S, L, A and B Stages)
Gives the stage verdict of every batch on your list from each unit’s dissolution result: pass, go to the next stage (with the units to test) or fail, by the harmonised acceptance tables — immediate release S1 to S3, extended release L1 to L3 against the stated ranges, and delayed release by its acid stage (A1 to A3) and buffer stage (B1 to B3). These are the tables of the harmonised dissolution test (Japanese Pharmacopoeia 6.10, harmonised with Ph. Eur. 2.9.3 and USP <711>, which ICH Q4B makes interchangeable).
Enter Q (or the stated ranges), choose whether values are rounded to the decimals of the limit, and paste each batch’s values in testing order — or open the percent-released calculator’s Excel file as a batch. Every criterion of every stage tested is listed as met or not met. The free preview shows the criteria, the limits that apply and each batch’s stage and verdict; the means and lowest values stay hidden, and the PDF, Excel and Print record opens with an Ultimate pass.
How to use it
- Choose immediate, extended or delayed release, and enter Q (for delayed release, the buffer stage’s Q) or the stated ranges of an extended-release product.
- Paste the batches: immediate release, the batch then its values in testing order; extended release, one line per unit with a value per range; delayed release, one line per unit with its acid and buffer values.
- Read each batch’s verdict and the criteria of each stage; for a batch that goes on, test the next units and add them after the first ones.
- Without a pass the report stays a free preview with its computed figures hidden; the PDF, Excel and Print record unlocks with an Ultimate pass.
Examples
Q = 80 %: 92, 95, 88, 90, 94, 91
Each of the 6 not less than Q + 5 % (85 %): passes at S1
Q = 80 %: 88, 83, 90, 86, 84, 87
Two values below 85 %: go to S2 and test 6 more units
Ranges 1 h 20 to 40 %, 4 h 45 to 65 %, not less than 80 % at 8 h; six units within
Every value within each range and none below 80 % at 8 h: passes at L1
Common uses
- Batch release: the stage verdict of every batch tested in a week.
- Reviewing a stability pull before signing it off.
- Planning how many units the next stage needs.
- Checking extended-release profiles against several stated ranges at once.
Immediate release (Acceptance Table 6.10-1)
- S1, 6 units: each not less than Q + 5 %.
- S2, 6 more: the mean of the 12 not less than Q, and no unit less than Q − 15 %.
- S3, 12 more: the mean of the 24 not less than Q, not more than 2 units less than Q − 15 %, and no unit less than Q − 25 %.
Q and the 5 %, 15 % and 25 % are percentages of the labelled content.
Extended release (Acceptance Table 6.10-2)
- L1, 6 units: no value outside each stated range and none below the stated amount at the final test time.
- L2, 6 more: the mean of the 12 within each range and not below the final amount; no value more than 10 % of the labelled content outside each range or below the final amount.
- L3, 12 more: the mean of the 24 within each range and not below the final amount; not more than 2 of the 24 more than 10 % outside each range or below the final amount; and none more than 20 %.
Delayed release (Acceptance Tables 6.10-3 and 6.10-4)
- Acid stage: A1, no value above 10 % dissolved; A2 and A3, the mean of the 12 or 24 not more than 10 % and no value above 25 %.
- Buffer stage: B1 to B3 as S1 to S3, with the buffer stage’s Q.
Testing continues through the levels unless both stages conform at an earlier one.
Sources
- The Japanese Pharmacopoeia, English version — 6.10 Dissolution Test, harmonised with the European Pharmacopoeia and the U.S. Pharmacopeia: Acceptance Tables 6.10-1 to 6.10-4
- ICH Quality guidelines — Q4B: the harmonised dissolution test texts are interchangeable
Limitations
- A monograph or specification may set other criteria: they win over these tables.
- The values are the percentages of the labelled content you have worked out; the percent-released calculator gives them from the absorbances or areas.
- Rounding to the decimals of the limit is the usual way to compare; choose “as entered” where your procedure compares unrounded values.
- Up to 200 batches at a time, checked on your device in a moment.
- MySmartCoPilot is not affiliated with or endorsed by the pharmacopoeias or ICH. This record applies the acceptance tables of the method you choose; your QA approves the result.
Privacy
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Your results stay in this browser and are never sent anywhere. The PDF and Excel files are made on your device.
Frequently asked questions
What do I get without a pass?
Without a pass, Dissolution Acceptance Stage Checker (S, L, A and B Stages) shows the method, the limits that apply and the verdict for your input; computed figures stay hidden until the pass. Until you unlock it, the result can’t be downloaded or printed. An Ultimate pass, a one-time payment unless you choose automatic renewal, unlocks the full result. The pricing page lists the passes and their prices.
What does the Ultimate pass add here?
This tool in full, and every other Pro, Premium and Ultimate tool, for 7 days, 30 days or a year (a pass bought with PayPal leaves out email-address extractors). The pass is a one-time payment unless you choose automatic renewal.
What does Q + 5 % mean at S1?
Each of the 6 units must have dissolved not less than Q plus 5 percentage points of its labelled content: with Q = 80 %, at least 85 %.
When does a batch go to S2 or S3?
When the results do not conform at S1, 6 more units are tested and the 12 are judged at S2; when they do not conform at S2 either, 12 more are tested and the 24 judged at S3. A batch that does not conform at S3 fails.
Are the values rounded before they are compared?
By default each value and each mean is rounded to the decimals of the limit (whole per cent for Q = 80 %), a 5 in the next decimal rounding up; you can compare the values as entered instead.
How are several ranges of an extended-release product judged?
Each criterion applies to each range: at L1 every value must lie within every stated range and none may be below the stated amount at the final test time.
Can I use the percent-released calculator’s results?
Yes: open its Excel file and its vessels become one batch, with the value at the last time point for immediate release. For extended release, enter the stated ranges first: each vessel then takes the time points of the ranges (“1 h” finds a “60 min” column too), or every time point when the sheet does not have them all.