Stability is an important quality characteristic of pharmaceutical products. The purpose of evaluating stability is to demonstrate how the quality of a drug substance or drug product varies under the influence of a variety of environment factors, such as temperature, humidity, and light, and to establish the recommended storage conditions and shelf-life for the drug product.
In stability studies, products are packaged in suitable containers and stored under a variety of environmental conditions. Most commonly, the products are stored under exaggerated (also known as “accelerated”) and normal (or “long term”) conditions. Under accelerated conditions, the product is subjected to elevated levels of temperature and humidity. Under long term conditions, the product is stored in an environment that is designed to mimic that of a normal room atmosphere.
At pre-defined time intervals, samples of the product are removed from storage and tested for characteristics such as purity, degradation products, and observed for physical changes. These types of studies enable product manufacturers to select the optimum formulation, packaging containers, recommended storage conditions, and expiration dates for final packaged products.
Galbraith’s stability testing program is compliant with ICH Q1A(R2) – Stability Testing of New Drug Substances and Products. We offer accelerated conditions at 40°C and 75% relative humidity (RH), and long term storage conditions at 25°C and 60% RH.
To learn more about ICH guidelines for stability testing, click Learn About ICH Q1A(R2) below. For more information regarding our stability testing services, contact us at 865.546.1335 or click Request a Quote below.