Run ICH and Related Guidelines in Atlas SUNTEST instruments.
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Packaged and non-packaged pharmaceutical products are sensitive to light and heat. ICH Q1B is the internationally recognized standard guideline for photostability tests of new drug substances and products. It deals with both forced degradation stress tests and confirmatory studies of the API, drug product and excipients.
Understanding the requirements, available test technology, and how to translate ICH specifications into instrument parameters and test durations, is critical to performing tests correctly and obtaining the required product approvals.
In this Online Seminar you learn about:
- Impact of light and heat on drug products, API’s, packaging
- ICH Q1B and VICH GL5 Guidelines
- Light sources and sample preparation
- Technology, instrumentation, testing guidance