FDA Adds 12 High-Risk Nitrosamine Impurities, Spotlighting Meglumine-Related NDSRIs

Recently, the U.S. FDA updated its Nitrosamine Impurities Acceptable Intake Limits database, adding 12 new high-risk nitrosamine impurities. Among them, meglumine-related nitrosamine drug substance-related impurities (NDSRIs) have emerged as a major pharmaceutical safety concern, involving more than ten commonly used drugs such as delafloxacin meglumine, iopamidol meglumine, and gadodiamide meglumine.

This update once again sounds the alarm for the pharmaceutical industry. As a widely used pharmaceutical excipient, meglumine is facing increasingly prominent NDSRI contamination issues, posing significant safety risks and regulatory pressures across the sector.

Accurate Detection Becomes Urgent

To address this challenge, CATO has launched the N-Nitrosomeglumine-¹⁵N internal standard, manufactured in strict compliance with ISO 17034 quality standards, providing pharmaceutical companies with a stable and reliable analytical tool.

Product Information

• Name: N-Nitrosomeglumine-¹⁵N
• Chinese Name: N-亚硝基葡甲胺-¹⁵N
• Catalog No.: LCAD304328
• Molecular Formula: C₇H₁₆N[¹⁵N]O₆
• Molecular Weight: 225.21
• Concentration: 100 μg/mL

Advantages of N-Nitrosomeglumine-¹⁵N Internal Standard

1. Enhanced Method Precision

Nitrosamine impurities occur at extremely low levels in pharmaceuticals (from ppb down to ppt range), making them difficult to accurately detect with conventional methods. As a stable isotope-labeled compound, N-Nitrosomeglumine-¹⁵N improves stability during mass spectrometry ionization, thereby increasing analytical precision and reducing the risk of false negatives or false positives.

2. Correction of Matrix Effects

Complex drug matrices often cause matrix effects that compromise mass spectrometry accuracy. By adding N-Nitrosomeglumine-¹⁵N at the early stages of sample preparation, both the internal standard and target analyte undergo the same losses and matrix effects, enabling accurate bias compensation and ensuring reliable quantitation.

3. Improved Method Robustness

The use of isotope-labeled internal standards significantly enhances method robustness and reproducibility. Throughout sample preparation, chromatographic separation, and mass spectrometric detection, the internal standard acts as a real-time calibration factor, minimizing the influence of operational variability and environmental changes on analytical results.

4. Regulatory Compliance

The application of N-Nitrosomeglumine-¹⁵N supports the development of standardized analytical workflows that meet the increasingly stringent requirements of the FDA and other regulatory authorities, providing a solid technical foundation for companies facing future compliance challenges.

In an environment of tightening regulations and escalating technical demands, the adoption of N-Nitrosomeglumine-¹⁵N is no longer merely a technical choice—it is a strategic imperative for ensuring drug safety, maintaining quality compliance, and safeguarding long-term market competitiveness.

CATO remains committed to delivering high-quality analytical solutions to help the pharmaceutical industry collectively address the challenges posed by nitrosamine impurities.