Nitrosamine analysis content pack

Complete nitrosamine impurity analysis with confidence, using fit-for-purpose solutions that provide robust sensitivity. Simplify this important analytical task using SCIEX OS software, a compliant-ready software platform that is easy-to-use for data acquisition, processing and reporting.

Nitrosamines can pose serious health risks, and regulatory agencies like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have strict guidelines to ensure drug safety. These guidelines apply not only to products commonly highlighted for nitrosamines but also to all potentially contaminated drugs and processes in a company’s portfolio of active pharmaceutical ingredients (APIs).

Developed to help you address complex impurity and nitrosamine assays, this content pack combines proven workflows, expert guidance, and practical methodologies for confident decision-making across development and manufacturing.