stability-shelf-life-testing Caron - Stability/Shelf Life

Stability & Shelf Life Testing

Accurate, dependable, and easy to use test chambers are crucial for stability testing of active pharmaceutical ingredients, photostability testing of drug product samples, or shelf life testing of finished pharmaceutical product.

  • Testing is performed in accordance with major global and regional guidelines:
  • ICH Stability and Photostability testing of new drug substances and products.
  • The US FDA, EU EMA & Health Canada all use ICH’s guidelines
  • VICH Stability testing of Veterinary drug substances and medicated premixes
  • WHO & ASEAN Stability testing for climatic zone IVb drugs
  • Freeze/thaw testing, simulating cold-climate product temperature excursions

Specific tests include:

  • ICH Q1A Accelerated Testing (40°C, 75% RH)
  • ICH Q1A Intermediate Testing (30°C, 60% and 65% RH)
  • ICH Q1A Long-term Testing (25°C, 65% RH or 30°C, 65% RH)
  • ICH Q1A Refrigerated Product Testing (5°C or 25°C, 60% RH)
  • ICH Q1B & VICH GL5 Photostability testing
  • ASEAN/WHO stability testing (30°C, 75%RH, or 40°C, 75%RH)

To assure consistent and meaningful results, chambers used for these tests need to feature tight parameter control, uniformity and stability over long periods of time. Depending on test selected, parameters may include sub-ambient or elevated temperature, elevated humidity, and both visible and UV-spectrum light.

Other markets, such as food, nutritional supplements, cosmetics, and health and beauty products perform similar product and packaged product shelf life testing. ICH guidelines are commonly followed in these markets.