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Nitrosamine Analysis in Elastomer and Rubber Products

Application Note:

Nitrosamine Analysis in Rubber Toys by gas chromatography
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Introduction

Nitrosamines can form during the manufacture of elastomer and rubber products. Items such as teats, soothers, toys, and similar materials can release small amounts through regular use. which is why many regions set strict limits for children’s products. Testing helps confirm that these products meet the safety limits set by international bodies.

Gas chromatography with TEA detection offers a precise way to measure a broad range of nitrosamines in line with standards such as BS EN 71-12:2016 and BS EN 12868:2017.

 

Nitrosamines_Rubber_Toys

The Challenge

 

Keeping nitrosamines under control isn’t as straightforward as it seems

 

Nitrosamines can form when nitrites or nitrates react with secondary amines during production. Many rubber and elastomer processes create the conditions for this reaction, which makes these compounds hard to avoid without active monitoring. Small amounts can still appear even when manufacturers reduce sources of contamination.

The limits set by international regulations are low. Many regions also apply limits to the total amount of nitrosamines in a product. Testing confirms that materials remain within those limits.

Some nitrosamines, including NDELA, are less volatile, which makes them harder to analyse using standard techniques. Detecting all required compounds at low concentrations calls for a sensitive and specific approach that can separate and measure each compound clearly.

 

Baby_Pacifier_Dummy_Nitrosamine

The Solution

 

Measuring nitrosamines with gas chromatography and TEA 


Gas chromatography with TEA detection gives you the sensitivity needed to measure nitrosamines at the low levels set by international safety standards. The Ellutia 200 Series GC separates each compound, while the Ellutia 810 TEA provides nitrogen-specific detection that suits this type of analysis.

The method covers the full range of nitrosamines listed in BS EN 71-12:2016 and BS EN 12868:2017. Less volatile compounds such as NDELA can be treated with a BSTFA + TMCS derivatisation kit so they can pass through the GC column and be detected by the TEA.

200_Series_GC_Thermal_Energy_Analyser_TEA

 

This approach gives clear separation, stable baselines, and detection limits that match the requirements of the standard. It offers a dependable way to test rubber and elastomer products before they reach the market.

 

 

Method Overview

 

How nitrosamines are analysed using gas chromatography and TEA

 

Samples are prepared in line with BS EN 71-12:2016 and BS EN 12868:2017. The method covers a wide range of nitrosamines, including compounds that are less volatile. These can be treated with a BSTFA + TMCS derivatisation kit so they can move through the GC column and reach the TEA detector.

A small volume of the prepared sample is injected into the Ellutia 200 Series GC. The GC separates each nitrosamine as it travels through the FFAP column under controlled temperature and flow conditions. Once separated, the compounds pass into the Ellutia 810 TEA, which detects nitrosamines based on their nitrogen content.

 

Typical GC Conditions

  • Injector temperature: 220 °C

  • Liner: Focus liner with wool

  • Carrier gas: Helium

  • Constant pressure: 2 psi

  • Injection mode: Splitless

  • Column: EL-FFAP, 15 m × 0.32 mm × 0.5 µm

TEA Setting

  • Detector temperature: 250 °C

  • Pyroliser temperature: 500 °C

  • Sensitivity: 230

  • Vacuum: 0.39 torr

  • Oxygen flow: 2 psi

Column temperature program:

The column is run on a stepped temperature programme, starting at 60 °C and ramping through one or more stages to a higher final temperature with a short hold time.

This setup provides the separation and sensitivity needed to measure nitrosamines at the low concentrations required by international safety standards.

This setup provides the separation and sensitivity needed to measure nitrosamines at the low concentrations required by international safety standards.

Results and Reliability

 

What the analysis shows


The method was applied to a range of rubber and elastomer products, including teats, soothers, balloons, looms, toys, and finger paints. Nitrosamines such as NDMA and NDELA were detected in most samples, although all levels remained below the limits set by international regulations.

Quantitation limits between 1 and 5 μg/kg were achieved, matching or exceeding the levels stated in BS EN 12868:2017. Chromatograms showed clear separation across the full set of nitrosamines covered by the standard. Baselines were stable, and low-level peaks were easy to identify.

In the samples tested, NDMA and NDELA were present in every product at low concentrations. NDEA was only detected in the balloon sample. None of the items exceeded the limits applied to baby and children’s products, which confirms that the GC-TEA setup can measure nitrosamines at the levels required for routine safety checks.

The nitrogen-specific design of the TEA provides higher sensitivity for nitrosamines than other detectors, which helps when working with small peaks in complex matrices. The system produced consistent results across multiple product types and concentration ranges, giving laboratories a dependable way to monitor nitrosamines in these materials.

 

Learn More

 

Get the full method and results


If you’d like to see the full details behind this testing method, you can download the complete application note. It includes chromatograms, calibration data, and the exact conditions used for the analysis. It’s a handy reference if you want to check your own setup or compare results.

 

 

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Frequently Asked Questions