Stability Testing for Temperature and Humidity

By Rachel Kohn | June 15, 2016

Stability Testing for Temperature and Humidity

Stability testing is a critical part of drug and medicinal product development to determine the shelf life of such products under a variety of environmental conditions such as temperature and humidity.  Family prescriptions likely have on their label a recommended “use by” date and notification if special storage conditions should be observed. The regulatory mandate for stability testing in the United States is contained in 21 CFR Part 211 Section 166.

Tests to determine storage requirements and shelf life for drugs and other medicinal products are taken under a variety of imposed and tightly controlled environmental conditions.  Because testing time can be extensive accelerated studies are permitted to support tentative expiration dates provided full shelf life studies are being conducted.

 

Temperature and Humidity Test Chamber Specs

Stability testing is performed in specially designed test chambers capable of duplicating a broad range of temperature … Read the rest