Shelf-Life Testing – Stability & Expiry Determination

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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 At predetermined intervals, the samples are withdrawn and tested for critical quality attributes such as potency, degradation, appearance, pH, moisture content, and dissolution profile.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