
Disintegration Testing – Ensuring Effective Drug Release
Overview:
Disintegration Testing evaluates how quickly a solid oral dosage form, such as a tablet or capsule, breaks down into smaller particles when placed in a specific fluid medium. This test is essential for confirming that the drug will release its active ingredients efficiently upon ingestion, enabling proper absorption in the body.
Test Description:
The dosage form is placed in a disintegration test apparatus containing a prescribed liquid (typically water, simulated gastric, or intestinal fluid) and maintained at body temperature (37°C ± 2°C). The test measures the time it takes for the sample to fully disintegrate without leaving a palpable core.
Purpose & Benefits:
- Confirms bioavailability readiness by ensuring breakdown before dissolution
- Assesses product performance during quality control and batch release
- Required for regulatory compliance and method validation
- Helps detect formulation defects or changes in manufacturing
Industries Served:
- Pharmaceutical Manufacturers
- Generic Drug Developers
- Nutraceuticals and Dietary Supplements
- Clinical Trial Material Providers
- Dissolution Testing – Drug Release Profiling
- Shelf-Life Testing – Stability & Expiry Determination
- Assay of Residual Solvents – Volatile Impurity Analysis
- Sterility Testing – Assurance of Microbial Purity
- Potency Testing – Verifying Therapeutic Efficacy
- Fungal and Bacterial Contamination Testing
- Heavy Metal Testing – Ensuring Product Safety & Regulatory Compliance
- pH Testing – Ensuring Product Stability, Safety, and Compliance
- Stability Testing of Biological Products
- Moisture Content Testing – Ensuring Stability, Efficacy, and Shelf-Life of Drug Products