Content Uniformity (USP <905>)
Calculate Acceptance Value (AV) for Dosage Units
Stage 1 Results (% Label Claim)
Stage 2 Results (% Label Claim)
Acceptance Value (AV):
0.00
Status (L1 Check):
-
Mean (X̄):
0.00
Std Dev (s):
0.00
Reference Value (M):
0.00
Sample Size (n):
10
Performed By:
Name:
Date:
Checked By:
Name:
Date:
About USP <905> Content Uniformity
The Content Uniformity test ensures that every dosage unit (tablet, capsule, etc.) contains the intended amount of drug substance within a narrow range.
Calculation Logic
The Acceptance Value (AV) is calculated as: AV = |M - X̄| + ks
- X̄: Mean of individual contents.
- k: Acceptability constant (2.4 for n=10, 2.0 for n=30).
- s: Sample Standard Deviation.
- M: Reference value (depends on Target T and Mean X̄).
Reference Value (M) Rules (T=100)
- If X̄ < 98.5% → M = 98.5%
- If 98.5% ≤ X̄ ≤ 101.5% → M = X̄
- If X̄ > 101.5% → M = 101.5%
Labels: Content Uniformity calculator