Understanding Disintegration and Dissolution in Pharma Testing

Introduction

In pharmaceutical development and quality control, disintegration and dissolution tests are two fundamental but often misunderstood procedures. While both assess tablet behavior in liquid environments, they measure very different properties — and serve distinct regulatory purposes.

What Is Disintegration Testing?

Disintegration testing determines the time it takes for a tablet or capsule to break down into small granules or particles when immersed in a specified liquid medium (usually water or simulated gastric fluid).

This test is typically described under USP <701> or Ph. Eur. 2.9.1 and focuses on physical disintegration — not how much drug dissolves. It's commonly used for immediate-release formulations.

What Is Dissolution Testing?

Dissolution testing, on the other hand, measures the rate and extent to which the active pharmaceutical ingredient (API) goes into solution over time under standardized conditions.

This test is detailed under USP <711> or Ph. Eur. 2.9.3, and is a key requirement for:

• Drug release profiling
• Bioavailability assessment
• Regulatory filings and stability studies

Key Differences Between Disintegration and Dissolution

Aspect	Disintegration	Dissolution
What it measures	Physical breakdown of dosage form	Release of API into solution
Main purpose	Confirms dosage form integrity	Predicts absorption and therapeutic effect
Time sensitivity	Measures time to break apart	Measures time and % of API dissolved
Regulatory use	Basic QC for IR tablets/capsules	Required for bioequivalence and NDA/ANDA
Equipment used	Disintegration tester with baskets	Dissolution tester with paddles or baskets

When to Use Each Test

Use disintegration testing for simple, immediate-release products where dissolution is predictable.

Use dissolution testing when drug solubility, release rate, or bioavailability are critical — especially in modified-release, poorly soluble, or regulatory-sensitive products.

HUANGHAI Testing Instruments for Disintegration & Dissolution

• Disintegration Tester Features:
  • Complies with USP/Ph. Eur. standards
  • 1 or 2 station configurations
  • Temperature-controlled water bath
  • User-friendly digital timer and control panel
• Dissolution Tester Features:
  • 6- or 8-position paddle/basket system
  • Precise temperature and rotation control
  • Optional auto-sampling and analysis modules
  • Real-time data display and reporting

👉 Explore Our Disintegration Instruments →

👉 Explore Our Dissolution Instruments →

Conclusion

Although often confused, disintegration and dissolution tests play very different roles in pharmaceutical development. By using both appropriately, you can ensure regulatory compliance, optimize formulation performance, and deliver safe and effective products.