ICH Stability Testing
Microtest is an industry leader in stability testing (pharmaceutical) that complies with International Conference on Harmonisation (ICH) guidelines.
Before a drug product is submitted for regulatory approval, ICH stability testing helps demonstrate it will continue to be safe and efficacious for its stated shelf life. Real-time ICH stability testing is conducted at room temperatures to reproduce actual storage conditions. Accelerated stability testing occurs at higher temperatures — up to 55 °C — to simulate longer spans.
Microtest typically tests three conformance lots, to some target of 6, 9, 12, 18, or 24 months. Total elapsed time of all testing is usually 1 year or less. We conduct tests for sterility, endotoxins, and particulates. We also check that the concentration of active ingredients is within specifications, and watch for evidence that real-time or accelerated aging has affected drug concentration or purity. We are one of the few laboratories that even offer photostability testing to monitor the effect of prolonged light exposure.
Unlike some other laboratories, at Microtest advanced SCADA systems monitor test chambers 24 hours a day, 7 days a week. So customers and regulators alike can be sure humidity and temperature remain within prescribed ranges. And since we offer a full range of drug testing at a single source, products aren’t exposed to temperature or humidity hazards in transit between tests.