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Content Uniformity Acceptance Value (AV) Calculator

USP <905> / Ph. Eur. 2.9.40 Uniformity of Dosage Units · Stage 1 (n=10) and Stage 2 (n=30) · L1/L2 verdicts

Paste the individual content results (% of label claim, one per line or comma-separated) and get the acceptance value with the stage-appropriate constants and the pass/fail verdict.

The calculation, exactly

AV = |M − X̄| + k·s, with k = 2.4 for n = 10 (Stage 1) and k = 2.0 for n = 30 (Stage 2). For T ≤ 101.5: M = X̄ when 98.5 ≤ X̄ ≤ 101.5, M = 98.5 when X̄ < 98.5, M = 101.5 when X̄ > 101.5. Pass when AV ≤ L1 = 15.0; at Stage 2 additionally no individual unit may lie outside 0.75·M … 1.25·M (L2 = 25). s is the sample standard deviation. Definitions per USP–NF General Chapter <905> and the harmonised Ph. Eur. 2.9.40.

QC work aid — release decisions follow your pharmacopoeial procedure and quality system, not a web page. For T > 101.5 the chapter's alternative M rules apply; this page implements the standard T ≤ 101.5 case.

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