Microtest Laboratories is an Industry Leader in ICH Stability Testing
Posted on: Tuesday, 26 May 2009, 09:20 CDT
Before a drug product is submitted for regulatory approval, ICH stability testing helps demonstrate that the product 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 degrees Celsius -- 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. Microtest conducts tests for sterility, endotoxins, and particulates. Microtest also checks 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. Moreover, Microtest is one of a few labs that offer photostability testing to monitor the effect of prolonged light exposure.
"Unlike some other labs, at Microtest advanced SCADA systems monitor test chambers 24 hours a day, 7 days a week. So customers and regulators can be sure humidity and temperature remain within prescribed ranges," said
Microtest is widely recognized for its problem-solving expertise in pharmaceutical contract manufacturing, aseptic processing, and pharmaceutical packaging. Services include single-source production and testing, plus dedicated product management.
For more information, visit Microtest Laboratories on the Web at www.microtestlabs.com/aseptic-processing/stabilty, or call 1-800-631-1680.
Or, visit Microtest at the 2009 Bio International Convention in
About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in
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SOURCE Microtest Laboratories
Source: PR Newswire
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