Content Uniformity Acceptance Value Calculator
Acceptance value is the number that decides whether a batch passes uniformity of dosage units by content. It combines how far the mean sits from the target with how scattered the individual results are.
Your numbers
15.0 in the compendial tests for T equal to 100 percent.
Your results
Simplified for target content T equal to 100 percent. Compendial rules include further criteria for stage 2, individual unit limits and other targets. Confirm with the current official text.
Acceptance value vs standard deviation
Sweeps Standard deviation from 0 to 8, holding your other inputs fixed.
Quality results trending
Optional expert review of how lab results and batch data could be trended from your systems.
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How to use it
Enter the mean content as a percentage of label claim and the sample standard deviation, then choose how many units were tested. The calculator reports the acceptance value, whether it falls under 15, and how much standard deviation you could still afford at that mean. Use the chart to see how quickly a rising spread consumes the limit.
The formula
AV = |M - mean| + k x s. M equals the mean if it lies between 98.5 and 101.5 percent. If the mean is below 98.5, M is 98.5, and if above 101.5, M is 101.5. The constant k is 2.4 for 10 units and 2.0 for 30 units. A mean of 99.2 with SD 2.1 gives AV near 5.0, a comfortable pass. A mean of 95 with SD 3 gives AV above 10.
Common mistakes
Using population rather than sample standard deviation is the most common one: the sample SD divides by n minus 1. Others include entering results as absolute mg instead of percent of label claim, and forgetting that the individual unit limits (such as a unit more than 25 percent from M) still apply in the full test. Treat this as a screening aid for trending.
Frequently Asked Questions
Is AV the only pass criterion?
No. The compendial test also limits individual units relative to M and moves to a second stage when the first fails. This calculator covers the main AV step only.
Why does k change with sample size?
Larger samples give a better estimate of the true spread, so the penalty factor on the standard deviation is smaller.
What if my target is not 100 percent?
The reference value M follows different rules for other targets. Use the official text for those cases.
Can I use it for blend uniformity?
It is useful as a trending screen, but blend uniformity criteria are set in your validation protocol and are not the same as dosage unit acceptance.
Netray can feed LIMS results and batch records into a single quality review view on your own infrastructure. Ask for an expert review.
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