Nitrosamine Risk Mitigation in Pharmaceuticals |
Focus on Excipients and Nitrite Control
Abstract: The detection of nitrosamine impurities in pharmaceutical products has raised significant regulatory and public health concerns already since 2018. However, reducing potential nitrosamine formation in formulations containing vulnerable amines remains a critical topic.
This white paper discusses risk assessment strategies, regulatory expectations, and mitigation measures, focusing on excipient selection and nitrite trace quantification. It specifically highlights lactose and MEGGLE’s low-nitrite grades, validated by ion chromatography (IC) methods.
The paper also addresses analytical challenges, matrix interference, and best practices in trace-level nitrite testing. These insights aim to guide pharmaceutical manufacturers in establishing robust control strategies to minimize the risk of nitrosamine formation.
Request Nitrite Control Whitepaper
Mit * markierte Felder sind Pflichtangaben.
