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).

This content pack equips you with methods for detecting impurities both before and after manufacturing, enabling you to stay ahead of regulatory requirements. With SCIEX solutions, you’ll have the tools to reliably monitor impurities at every stage, without the stress of uncovering stability issues or degradation products.