Detection of speciated volatile nitrosamines in pharmaceuticals using GC-TEA

In the pharmaceutical industry, the safety of medications is a critical concern, particularly with the risk posed by nitrosamine contamination. Nitrosamines, such as N-Nitrosodimethylamine (NDMA), are carcinogenic compounds that may form during drug manufacturing under specific conditions. Addressing this challenge, Ellutia’s 800 series Thermal Energy Analyser (TEA) provides a sophisticated solution for the accurate analysis of volatile nitrosamines through Gas Chromatography coupled with Thermal Energy Analysis (GC-TEA).

Nitrosamines typically arise when an amine - often a secondary amine - reacts with nitrosating agents like nitrites, either under acidic conditions or at elevated temperatures during the manufacturing process. The identification and quantification of these contaminants are vital, as demonstrated by the NDMA findings in Ranitidine, a formerly widespread antacid that was revealed to form NDMA over time under standard storage conditions.

Under EU Regulation (EC) No 726/2004, which establishes acceptable limits for 27 different nitrosamines, pharmaceutical manufacturers are mandated to perform risk assessments and conduct regular testing for these compounds. This regulation ensures that all medications adhere to safety standards prior to reaching consumers.

The operation of the GC-TEA system by Ellutia involves separating nitrosamines within the GC column, followed by their elution into the Pyrolyser. Here, the nitrosamines decompose to release nitric oxide (NO), which is subsequently detected by the TEA after reacting with ozone. This sequence facilitates the precise quantification of the nitrosamines present.

To prepare pharmaceutical samples for analysis, a process involving methanol extraction, centrifugation, and filtration is employed. This preparation is essential for obtaining accurate and reliable results. Notably, the TEA by Ellutia is recognised for its sensitivity and specificity, which significantly reduce background noise and interference - common issues in the detection of nitrosamines.

Incorporating the GC-TEA system into pharmaceutical testing protocols provides a robust mechanism for adhering to safety regulations and safeguarding public health. By offering detailed and reliable methods for analysing volatile nitrosamines, Ellutia reinforces the pharmaceutical industry’s dedication to drug safety and efficacy.

For further insight into volatile nitrosamine analysis by GC-TEA, including a focus on Metformin, join Ellutia’s upcoming webinar on 22nd May. Their experts will discuss these topics and more. Register now.

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