Content Uniformity — USP <905>

Acceptance Value (AV) Calculator

Calculate the Acceptance Value from individual dosage unit assay results, using the USP <905> Content Uniformity approach.

How the Acceptance Value Works

USP <905> evaluates content uniformity across individual dosage units (e.g., tablets, capsules) using the Acceptance Value (AV), which combines how far the mean is from target with how much individual units vary.

AV = |M − X̄| + k·s Where: X̄ = mean of individual unit results (% of label claim) s = sample standard deviation k = acceptability constant (2.4 for Stage 1, n=10; 2.0 for Stage 2, n=30 pooled) M = reference value: if 98.5% ≤ X̄ ≤ 101.5%, M = X̄ if X̄ < 98.5%, M = 98.5 if X̄ > 101.5%, M = 101.5

Acceptance Criteria

Stage	n	k	Criterion
Stage 1	10	2.4	AV ≤ L1 (15.0)
Stage 2 (if Stage 1 fails)	30 (pooled)	2.0	AV ≤ L1 (15.0), and no individual unit outside M ± (L2/100)·M, where L2 = 25.0

Interactive Calculator

Individual Unit Results (% of Label Claim) 98.5, 101.2, 99.8, 100.5, 97.9, 102.1, 99.0, 100.8, 101.5, 98.7

Comma or newline separated. 10 values for Stage 1, or 30 pooled values for Stage 2.

Stage Stage 1 (n=10, k=2.4) Stage 2 (n=30 pooled, k=2.0)

n

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Mean (X̄)

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Std. Dev. (s)

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Acceptance Value (AV)

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This calculator computes the AV per the standard formula for educational and preliminary assessment purposes. Confirm the individual unit range check (L2 criterion at Stage 2) and any product-specific L1/L2 values against your approved specification and the current USP <905> chapter before using results for batch disposition.