• Navigating Nitrite Levels in Pharmaceuticals: A Comprehensive Yet User-Friendly Solution

Sample Prep

Navigating Nitrite Levels in Pharmaceuticals: A Comprehensive Yet User-Friendly Solution

Oct 24 2023

If you're in the pharmaceutical industry, you're familiar with the intricacies of managing nitrosamine levels in your products. This isn't a mere regulatory obligation but a matter of public safety. Failing to effectively control nitrosamine can lead to dire consequences—financial losses due to large-scale product recalls, a tarnished brand reputation, and in the worst-case scenario, potential cancer risks for consumers.

A cornerstone in this management strategy is controlling the levels of precursor compounds, mainly nitrites, that lead to nitrosamine formation. Traditional technologies and methods have often faltered when it comes to precise measurement of nitrite content, particularly at low ppb levels. That's a major pain point for many in the field.

While the Automated Total Nitrosamine Analyser (ATNA) is mostly known for its prowess in nitrosamine screening, it’s equally effective in rapidly detecting nitrite content. And what sets it apart is its versatility. From raw materials to finished products, the ATNA can handle various types of samples and requires minimal preparatory work.

So, how does it work? You place your samples into headspace vials along with a specially-formulated reagent mixture. Our Robotic Autosampler takes it from there. It performs a chemical reaction, specifically targeted at nitrosamine and nitrite molecules, making the presence of a complex sample matrix a non-issue. The sample headspace is then directly injected into our highly sensitive TEA Detector. The TEA Detector uses chemiluminescence, a light-producing chemical reaction, to achieve high sensitivity and selectivity for this type of analysis, even detecting down to 1 ppb levels.

The best part? The ATNA is efficient, capable of analysing up to 10 samples per hour. And because there's no compound separation involved, it offers a straightforward yes-or-no outcome for whether a sample needs further investigation. For those who need to distinguish between nitrosamine and nitrite signals, a specially developed SPE cartridge is available for use during sample preparation.

In essence, what ATNA provides is a robust, yet user-friendly tool that gives you greater confidence and clearer insights into potential issues. This clarity helps you focus resources where they're most needed, thus avoiding unnecessary waste of time and resources on irrelevant samples. It’s a win-win—greater safety assurance with more efficient resource allocation.

So, if you find yourself struggling with the challenge of nitrite and nitrosamine control in pharmaceuticals, why not consider a streamlined, efficient solution like the ATNA? Given its capabilities, it could very well be the missing puzzle piece in your nitrosamine management strategy.

Intrigued? We invite you to contact us to explore how ATNA can offer a custom solution that addresses your specific challenges.

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