Analysis of speciated volatile nitrosamines in pharmaceuticals by GC-TEA

In the pharmaceutical industry, ensuring medication safety is paramount, especially given the potential risks posed by nitrosamine contamination. Nitrosamines, such as N-Nitrosodimethylamine (NDMA), are known carcinogens that can form under certain conditions during drug manufacturing. To tackle this issue, the 800 series Thermal Energy Analyzer (TEA) by Ellutia offers an advanced solution for the precise analysis of volatile nitrosamines using gas chromatography coupled with thermal energy analysis (GC-TEA).

Nitrosamines are typically created when an amine (commonly a secondary amine) reacts with nitrosating agents like nitrites. This reaction can occur under acidic conditions or high temperatures during the manufacturing process. The detection and quantification of these contaminants are critical, as exemplified by the case of Ranitidine - once a popular antacid medication - where NDMA was found to form over time under normal storage conditions.

According to EU Regulation (EC) No 726/2004, which lists permissible limits for 27 nitrosamines, pharmaceutical companies are required to conduct risk assessments and regular testing for nitrosamines in their products. This ensures that all medications meet safety standards before reaching consumers.

The GC-TEA system by Ellutia operates by separating the nitrosamines in the GC. They are then eluted into the Pyrolyser, which breaks down the nitrosamines to release nitric oxide (NO). This NO is detected by the TEA after reacting with ozone, allowing for precise quantification of the nitrosamines present.

In practical terms, pharmaceutical samples are prepared through a method involving methanol extraction, centrifugation, and filtration before being analysed by the GC-TEA. This preparation is critical for achieving accurate and reliable results. Ellutia's TEA is particularly noted for its sensitivity and specificity in reducing background noise and interference, which are common challenges in nitrosamine detection.

The integration of the GC-TEA system into pharmaceutical testing protocols offers a robust tool for ensuring compliance with safety regulations and protecting public health. By providing detailed and reliable methods for analysing volatile nitrosamines, Ellutia supports the pharmaceutical industry’s commitment to safety and efficacy in drug manufacturing.

Interested in learning more about Volatile Nitrosamine analysis by GC-TEA including Metformin analysis, join Ellutia’s webinar on 22nd May where their experts will be discussing the above and much more.

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