ContentUniformityQualityChecker

Content Uniformity Quality Checker — Calculation of AV for Uniformity of Dosage Units

ℹ️  Utility calculates Acceptance Value (AV) according to USP <905> and Ph. Eur. 2.9.40:
   • Input: 10 individual active substance contents (% of Label Claim).
   • Formula: AV = |M - x̄| + k * s
     - x̄: mean content
     - s: sample standard deviation
     - k: 2.4 (for n=10)
     - M: reference value (100.0 if 98.5 ≤ x̄ ≤ 101.5; otherwise boundary)
   • Passing Criteria (Stage 1): AV ≤ 15.0 AND all units within 75.0–125.0%.

⚠️  CRITICAL: AV > 15.0 → batch fails uniformity requirements!
   Any unit outside 75-125% results in automatic failure.

Usage:
 ContentUniformityQualityChecker.exe                            → demo mode (console output)
 ContentUniformityQualityChecker.exe input.csv output.json      → evaluate your data

Input format:
BatchNumber,Unit1,Unit2,Unit3,Unit4,Unit5,Unit6,Unit7,Unit8,Unit9,Unit10

Example:
 TAB-CU-2026-001,98.5,101.2,99.0,100.5,97.8,102.1,99.5,100.0,98.9,101.5

— WHY IS THIS NEEDED?
Content Uniformity (CU) ensures that each tablet or capsule contains the correct amount of active ingredient.
• This is a critical quality attribute for solid dosage forms with low API potency.
• USP <905> and Ph. Eur. 2.9.40 use a statistical approach (Acceptance Value) to assess variability.
• AV calculation accounts for both bias (accuracy) and spread (precision).
• Automation eliminates manual calculation errors for standard deviation and AV.

⚠️  CRITICAL:
• For Stage 1 (n=10), the AV limit is 15.0.
• If AV > 15.0 but ≤ 25.0, testing of additional 20 units may be required (Stage 2).
• Any unit outside 75.0–125.0% of Label Claim leads to batch failure at Stage 1.
• M value adjusts if mean deviates from 98.5–101.5%, penalizing for bias.

Key features:
• Automatic AV calculation per USP/Ph.Eur. formula.
• Check of individual limits (75-125%).
• Generation of LIMS-compatible JSON report.

Critical parameters:
• Acceptance Value (AV): <= 15.0
• Individual Limits: 75.0% - 125.0%

💡 Usage tips:
1. Ensure input data is expressed as % of Label Claim.
2. Use precise analytical methods (HPLC) to determine content in each unit.
3. If batch fails Stage 1, investigate process variability causes (mixing, compression).
4. This utility implements Stage 1 logic. Stage 2 (n=30) requires extended logic (not included in this version).

⚠️ Note: The calculation of M (reference value) is a key difference of the AV method from simple RSD calculation. It penalizes batches where the mean content significantly deviates from 100%, even if the spread (SD) is small.