Описание: E&Ls can enter a drug product during manufacturing, storage, and from the packaging system. The packaging components (those in contact with the drug product) can contain organic and inorganic E&L contaminants present a risk due to their inherent toxicity, while other compounds may adversely affect the efficacy, stability, and shelf-life of the drug. We will share an E&L study that shows both the potential for the drug product to become contaminated under extreme conditions (extractables), and the actual contamination that occurs during normal and extended storage (leachables).
Лектор: Jenny Nelson, PhD, Application Scientist, Agilent Technologies, Inc.
Продължителност: 28 минути
Дата: 16 август 2022, 22:30 ч.