Simplifying nitrosamine compliance with specified limit!
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Nitrite testing is not a pharmacopoeia requirement, however MEGGLE has developed a method using ion chromatography to accurately quantify nitrite, whereby the limit of quantification (LOQ) is 0.03 ppm. Values below this limit will be reported as < 0.03 ppm. Through additional validation we have demonstrated that we can safely specify a limit of ≤ 0.10 ppm (discussed as a reasonable target in the USP Nitrosamine Exchange Forum).
Why It Matters
Nitrosamines are a growing concern in pharmaceutical manufacturing. Regulatory authorities such as EMA & FDA have introduced strict guidelines to limit these potentially carcinogenic impurities. Excipients play a critical role – even trace amounts of nitrite can contribute to nitrosamine formation. At MEGGLE, we take action. Together with the Technical University of Munich (TUM), we have developed a high-precision analytical method to detect and quantify nitrite at ultra-low levels. With our new Low Nitrite excipients, we offer manufacturers a trusted solution to meet regulatory requirements and improve formulation safety.
Nitrosamine Risk Assessment Calculator
An interactive, science-based tool designed to help you assess nitrosamine formation risk and optimize acceptable nitrite limits in your formulation.
Learn More – Download Our Whitepaper
For a deeper dive into nitrosamine risk mitigation, we invite you to read our whitepaper: “Focus on Excipients and Nitrite Control – Nitrosamine Risk Mitigation in Pharmaceuticals”
Learn More – Expert Interview
Dr. Rebekka Spellerberg on Nitrosamine Risk Mitigation in Drug Formulation
Pharma Excipients interviewed Dr. Spellerberg from MEGGLE about the background and most important topics and findings of the a.m. study.