Disintegration Tester

Disintegration Tester – Tablet and Capsule Disintegration Testing

The Disintegration Tester is a pharmaceutical quality control instrument used to measure the time taken for tablets and capsules to break down (disintegrate) into particles when immersed in a liquid medium at 37°C ± 2°C under mechanical oscillation. Disintegration is a critical product specification for immediate-release tablets and hard-shell capsules.

Why Disintegration Testing Matters

A tablet that does not disintegrate within the specified time cannot release its active ingredient for absorption. Disintegration is a prerequisite (though not a guarantee) for dissolution and bioavailability. Most pharmacopoeias specify maximum disintegration times for different dosage forms.

Typical Disintegration Limits (IP/USP)

• Uncoated tablets: ≤ 15 minutes
• Film-coated tablets: ≤ 30 minutes
• Enteric-coated tablets: 60 min in acid, ≤ 60 min in buffer (Stage 2)
• Hard capsules: ≤ 15 minutes

Disintegration Tester Specifications

• Number of baskets: 2 or 6 (simultaneous testing)
• Basket stroke: 55 mm ± 2 mm
• Stroke frequency: 29–32 cycles/min
• Temperature control: 37°C ± 1°C (water bath thermostat)
• Timer: Digital countdown, individual per basket
• Basket mesh: 2 mm aperture, 316 SS wire mesh
• Fluid medium: 1,000 mL beaker per station

Standards

IP 2022, USP 43 <701>, BP 2023, ISO 14155, WHO Technical Report.

Contact JS Civil Lab Solutions at +91 93596 24761 for pricing, calibration, and validation support for GMP-compliant pharmaceutical QC laboratories.