DisintegrationTabletCapsuleQualityChecker

Disintegration Tablet/Capsule Quality Checker — Control of Tablet and Capsule Disintegration

ℹ️  Utility checks compliance of disintegration time with USP <701> / Ph. Eur. 2.9.1 requirements:
   • Stage 1: 6 units tested simultaneously.
   • Passing Criteria Stage 1: All 6 units must disintegrate within the specified time.
   • If 1 or 2 units fail, Stage 2 is conducted (additional 12 units).
   • Standard limits: 15 minutes (uncoated tablets), 30 minutes (capsules).

⚠️  CRITICAL: Presence of residue on the apparatus screen is considered non-disintegration!
   Exceeding disintegration time may indicate issues with granulation or compression.

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

Input format:
BatchNumber,LimitMinutes,Time1,Time2,Time3,Time4,Time5,Time6

Example:
 DIS-TAB-2026-001,15.0,8.5,9.0,8.0,9.5,8.2,9.1

— WHY IS THIS NEEDED?
Disintegration is a critical quality attribute for immediate-release solid dosage forms.
• Ensures availability of the drug substance for subsequent dissolution and absorption.
• USP <701> and Ph. Eur. 2.9.1 regulate the test method using basket-rack assemblies.
• The test is faster and simpler than full Dissolution testing and is often used for in-process control.
• Automation of calculation and criteria check eliminates interpretation errors of Stage 1/Stage 2 results.

⚠️  CRITICAL:
• Medium temperature must be maintained at 37 ± 2 °C.
• For coated tablets, disk assemblies may be used.
• If at least one unit fails Stage 1, the result is considered unsatisfactory until Stage 2 is performed.
• Stage 2 is passed if not less than 16 of 18 tested units (6+12) meet the limit.

Key features:
• Automatic check of Stage 1 criteria.
• Calculation of maximum and mean disintegration time.
• Generation of LIMS-compatible JSON report.

Critical parameters:
• Max Time: <= Limit (e.g., 15 min)
• Failed Units (Stage 1): 0

💡 Usage tips:
1. Ensure the basket rack moves freely up and down.
2. Use degassed water or buffer solution if specified in the monograph.
3. For gelatin capsules, preliminary soaking in water may be required.
4. Visually confirm complete disappearance of residue on the screen.
5. Regularly calibrate time and temperature of the disintegration apparatus.

⚠️ Note: Disintegration does not always correlate with Dissolution. For modified-release products or poorly soluble drugs, the disintegration test may be replaced or supplemented by the dissolution test.