MEGGLE low nitrite lactose grades – simplifying nitrosamine compliance with specified limit!

MEGGLE Excipients is excited to introduce our latest premium lactose grades – ensuring maximum safety in pharmaceutical formulations:

GranuLac® 200 Low Nitrite

Tablettose® 100 Low Nitrite

FlowLac® 100 Low Nitrite

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.

More about this topic! 

For a deeper dive into nitrosamine risk mitigation, we invite you to read our whitepaper, watch the expert interview with our colleague Dr. Rebekka Spellerberg or you can watch our webinar.