Chemical and microbiological testing at time intervals covering the shelf-life of a pharmaceutical finished product or active pharmaceutical ingredient (API) is used to monitor stability characteristics and support an expiration/retest date. Missouri Analytical has extensive knowledge and experience of the various phases of stability testing, such as method development, method validation, method verification (USP General Chapter 1226), method technology transfer, and chemical/microbiological testing. Time interval testing may be under FDA/ICH guidelines for accelerated conditions (40°C/75% RH) or room temperature conditions (25°C/60% RH).
Any of our chemical or microbiology tests, using compendial or customer methods, can be repeated at specific intervals to evaluate sample stability over time. We have limited long-term storage capability, or can receive samples when they need to be tested.