Content Uniformity Calculator
USP <905> – Evaluate dosage unit consistency
Unit Data Entry
Reference value for percentage calculations.
Individual Unit Contents
USP <905> Formula
AV = |M – X̄| + k·s
Where:
• M = Reference value (98.5–101.5% of label claim)
• X̄ = Sample mean
• k = 2.4 (for n=10)
• s = Sample standard deviation
Acceptance Criteria
Stage 1 (n=10)
- • AV ≤ 15.0
- • All units 85.0–115.0%
Stage 2 (n=30)
- • AV ≤ 25.0
- • At least 24 units 85.0–115.0%
- • All units 75.0–125.0%
Guidelines
Required for all solid oral dosage forms (tablets, capsules).
Perform on finished product and during stability.
High RSD (>6%) indicates formulation or process issues.
Applications
Batch release testing
Process validation
Stability testing