In the world of pharmaceutical manufacturing and quality assurance, nitrites have been identified as a considerable concern, walking the tightrope just got more challenging. These compounds can transform into nitrosamines, posing considerable health risks including carcinogenic properties.

The Unseen Challenge of Nitrites in Pharmaceuticals

Controlling nitrite levels has been identified as one of the best ways of controlling nitrosamine formation in products. The industry, therefore, needs an evolved methodology for accurate nitrite screening. It’s not just about ticking off regulatory boxes, but about preserving public health.

The Future of Risk Assessment in the Pharmaceutical Industry

Ellutia’s Automated Total Nitrosamine Analyser (ATNA) traditionally known for total nitrosamine content screening, can also offers an advanced solution for rapid nitrite content screening. This dual functionality propels ATNA into a cornerstone role in risk assessment and new product development processes.

Inside the ATNA System

• What Makes It Tick: The ATNA system integrates the Ellutia 800 series Thermal Energy Analyser (TEA), a headspace autosampler with a vortex mixer, heated agitator, and custom TEA inlet. This makes it a comprehensive package for unattended analyses of up to 120 samples over a 12-hour period.
• How It Works: In a two-step procedure, nitrosamines and nitrites are first reduced by hydrobromic acid, releasing nitric oxide into the headspace of the reaction vial. This is then sampled and analyzed in the TEA detector, detecting down to low ppb levels.

Advantages of Adopting the ATNA System

• ADVANCED RISK MITIGATION: THE SYSTEM DETECTS NITRITES BEFORE THEY CAN POTENTIALLY CONVERT INTO NITROSAMINES.
• RESOURCE OPTIMIZATION: WITH RAPID SCREENING CAPABILITIES, FOCUS ONLY ON PROBLEMATIC SAMPLES.
• UNPARALLELED ACCURACY: THE SPECIALISED SPE CARTRIDGE ENSURES YOU KNOW EXACTLY WHAT YOU’RE DEALING WITH—NITROSAMINES OR NITRITES.

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