WeightVariationTabletCapsuleQualityChecker

Weight Variation Tablet/Capsule Quality Checker — Control of Weight Variation for Tablets and Capsules

ℹ️  Utility assesses weight uniformity of dosage forms (tablets and capsules) according to USP <905> (Weight Variation Method):
     • Applicability: Uncoated tablets or hard capsules containing ≥50 mg API or ≥50% API of total weight.
     • Criterion 1: Not more than 2 units out of 20 may deviate from average weight by more than 5%.
     • Criterion 2: No unit may deviate from average weight by more than 10%.
     • Calculation based on weighing 20 individual units.

⚠️  CRITICAL: Weight deviation of any unit by more than 10% leads to immediate batch rejection!
     High weight variation is an indicator of problems with compression or capsule filling process.

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

Input format:
BatchNumber,ProductName,DosageForm,AverageWeight_mg,MinWeight_mg,MaxWeight_mg,UnitsOutside5Percent,UnitsOutside10Percent,TotalUnitsTested

Example:
  WV-2026-TAB-001,Paracetamol 500mg,Tablet,650.0,630.0,670.0,1,0,20

— WHY IS THIS NEEDED?
Weight uniformity is a critical quality parameter for ensuring patient dose uniformity.
For high-dose drugs, weight variation method is an alternative to Content Uniformity (CU) test, as it is less labor-intensive and non-destructive.

⚠️  CRITICAL:
• Method applicable only if API fraction is high. For low-dose drugs (<50 mg or <50%), Content Uniformity (CU) test is required.
• Balance Accuracy: Analytical balances with accuracy to 0.1 mg or better must be used.
• Statistics: If more than 2 units exceed 5% but none exceed 10%, retesting of another 20 units (total 40) is allowed.
• Capsules: Capsules must be cleaned of dust with a soft brush before weighing.

Key features:
• Automatic check of USP <905> criteria
• Separation of logic for tablets and capsules
• Control of extreme values (Min/Max)
• Generation of reports for QC departments and LIMS LabWare
• Compliance with GMP and Pharmacopoeia requirements

Critical parameters:
• Deviation >5%: ≤ 2 units
• Deviation >10%: 0 units
• Average Weight: Used as reference

💡 Usage tips:
1. Sampling: Units must be selected randomly from different parts of the batch.
2. Calibration: Balances must be calibrated before starting the test.
3. Conditions: Weighing is performed under controlled humidity and temperature.
4. Interpretation: If batch fails weight test, it automatically fails dosage uniformity requirement.
5. Process: High weight variation often indicates poor granulate flowability or issues with die/filler.

⚠️ Note: This method is a "surrogate" for content uniformity assessment. It assumes powder blend is homogeneous, and weight variation directly reflects API quantity variation.