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.
