Addressing Nitrosamine Analysis Challenges in Pharmaceuticals with the ATNA

Detecting nitrosamines in pharmaceutical products is essential for maintaining safety and ensuring regulatory compliance. Following high-profile recalls involving nitrosamine impurities, such as N-Nitrosodimethylamine (NDMA), regulatory bodies like the FDA and EMA now require pharmaceutical manufacturers to closely monitor their products for nitrosamine content. Nitrosamines form when amines (commonly present in active pharmaceutical ingredients) react with nitrating agents such as nitrites and nitrates, which may be present as residuals in raw materials or excipients. Under acidic or high-temperature conditions, these reactions are more likely, leading to nitrosamine formation throughout the product lifecycle. Recognizing the serious health risks, such as carcinogenic effects linked to nitrosamine ingestion, regulators have imposed strict detection thresholds. These limits, such as 96 ng/day for NDMA, are part of industry-wide efforts to prevent contamination. These requirements have driven the need for rigorous testing protocols, often pushing the limits of conventional methods.

The Automated Total Nitrosamine Analyser (ATNA) from Ellutia offers a transformative solution to meet these demands, using automation to streamline nitrosamine analysis for greater consistency, speed, and cost-effectiveness. Designed as a rapid, high-sensitivity screening tool, the ATNA delivers a clear pass/fail result on total nitrosamine content (ATNC) within minutes, allowing manufacturers to confidently determine which samples are free of nitrosamines and which require further analysis. The ATNA’s efficient workflow offers a faster, reliable screening approach that eliminates the need for more time-intensive speciated analyses unless necessary.

While conventional methods, such as GC-MS or LC-MS, have long been the standard for detecting nitrosamines at ultra-low levels, they can be labour-intensive, requiring complex sample preparation and long analysis times. This complexity can limit throughput in high-demand environments, adding costs and time delays. Compared to these methods, the ATNA’s automation capabilities enable high-throughput sample screening, offering rapid results with a simplified workflow.

Additionally, the ATNA’s flexible design supports various sample types, including raw materials and excipients, making it a valuable addition for pharmaceutical labs conducting routine screenings and risk assessments across different stages of production. The ATNA’s compatibility with existing GC systems further enhances its versatility by allowing integration for speciated analysis of volatile nitrosamines when deeper analysis is required. Laboratories can use the ATNA to flag only “at-risk” samples for follow-up testing, significantly reducing the need for complex analyses on all samples and enabling companies to better manage resources.

The automation capabilities of the ATNA bring both regulatory and operational advantages. The system provides high-quality, reproducible results with minimal operator intervention, helping laboratories maintain data integrity and compliance without overburdening their resources. By automating sample screening, companies can achieve reliable, high-volume testing at lower costs, streamlining the entire workflow and freeing up resources for targeted analysis where needed. With a sample capacity of 120 vials and a throughput of up to 8 samples per hour, the ATNA is well-equipped to handle the demands of busy pharmaceutical environments, improving operational efficiency and throughput.

In addition to pharmaceutical applications, the ATNA is also suitable for industries such as food and beverage, cosmetics, tobacco and even carbon capture where nitrosamine monitoring is critical for safety. Its rapid, reliable testing capability ensures compliance and safeguards product integrity across a wide range of applications.

The ATNA offers a powerful solution for nitrosamine testing by providing rapid, automated analysis that meets regulatory standards and supports efficient, compliant operations. By integrating the ATNA, laboratories can confidently manage their nitrosamine analysis needs, ensuring product safety and regulatory adherence in a cost-effective, streamlined manner.

Read our latest blog that focuses on NDMA impurities in Metformin.