
Shelf-Life Testing – Stability & Expiry Determination
Overview:
Shelf-life testing evaluates how long a drug product remains safe, effective, and stable under specific environmental conditions. This is essential for defining expiry dates, storage conditions, and ensuring regulatory compliance and consumer safety.
Test Description:
Drug samples are stored under accelerated, intermediate, or real-time (long-term) conditions inside stability chambers. At predetermined intervals, the samples are withdrawn and tested for critical quality attributes such as potency, degradation, appearance, pH, moisture content, and dissolution profile.
Purpose & Benefits:
- Establish shelf-life (expiry date) and recommended storage conditions
- Assess chemical, physical, and microbiological stability
- Support regulatory filings and product launches globally
- Ensure product quality and patient safety throughout distribution lifecycle
Industries Served:
- Pharmaceutical & Biotech Manufacturers
- Nutraceuticals & Dietary Supplements
- Cosmetic & Personal Care Products
- Medical Device Coatings and APIs
- Dissolution Testing – Drug Release Profiling
- Assay of Residual Solvents – Volatile Impurity Analysis
- Sterility Testing – Assurance of Microbial Purity
- Potency Testing – Verifying Therapeutic Efficacy
- Disintegration Testing – Ensuring Effective Drug Release
- 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