Calculate USP 905 acceptance value from 10 or 30 dosage-unit results, or from mean and sample standard deviation, with reference value M and staged criteria.

Use all 10 first-stage results or all 30 combined second-stage results, expressed as percent label claim.

Educational USP ⟨905⟩ / harmonized dosage-unit AV calculation using default L1 = 15 and L2 = 25. Confirm the applicable current chapter, monograph and validated procedure; this result does not authorize batch release.

Exactly 10 or 30 values to match the selected sample size. Separate with commas, semicolons, whitespace or line breaks; use decimal points, not grouped thousands.

Manufacturing target T

Default 100. Use the approved target; values above 101.5 change the upper reference-value boundary.

Related Calculators

Acceptance Value Formula

This calculator evaluates dosage-unit acceptance value (AV) using the harmonized content-uniformity relationship associated with USP ⟨905⟩.

AV = |M - x| + k s

Here x̄ is mean content as percent label claim, s is sample standard deviation with denominator n − 1, and M is the reference value. There is no standard-error division by √n. Use k = 2.4 for 10 units and k = 2.0 for 30 units.

Reference Value and Staged Criteria

When manufacturing target T ≤ 101.5%, M equals the mean within 98.5–101.5%; below or above that interval, M is the nearest boundary. When T > 101.5%, replace the upper boundary with T. T defaults to 100% or the approved manufacturing target.

The displayed defaults are L1 = 15 and L2 = 25. The first-stage AV must be ≤ L1. If it exceeds L1, the staged procedure uses 20 additional units and recomputes AV over all 30, including the first 10. At the second stage, AV must still be ≤ L1, and every individual result must lie within 0.75M–1.25M, inclusive. L2 sets the individual range; it is not a higher AV threshold.

Using the Calculator

Choose individual dosage-unit percentages or mean and sample SD. Match the selected 10- or 30-unit sample size. Individual results allow the second-stage range check; a summary alone cannot establish it. Calculate each active substance separately using appropriately derived content percentages. Custom requirements and procedure applicability must be checked against the current chapter and product monograph.

Example Problems

For 10 units with mean 100% and sample SD 2.5 percentage points, M = 100 and AV = 2.4 × 2.5 = 6. For mean 97% and SD 2, M = 98.5 and AV = 1.5 + 4.8 = 6.3.

A 30-unit sample with one result of 74% and the other 29 at 100% has mean 99.1333%, sample SD 4.74693 and AV 9.49386. Its AV meets the default limit, but 74% is below 0.75M = 74.35%, so the individual-range criterion fails.

Scope and Sources

The calculator compares unrounded values; displayed rounding can conceal a small limit exceedance. It supports educational checking, not product release approval. Consult the USP chapter and the public harmonized Japanese Pharmacopoeia chapter 6.02 for procedure details and applicable exceptions.