Nitrosamine Detection and Measurement

Methods for targeted and total nitrosamine analysis in pharmaceuticals, food ingredients, materials, and environmental systems.

Want to learn more about choosing the right system for your nitrosamine analysis? Download the Nitrosamine Analysis Buyers Guide.

 

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Nitrosamines appear in a wide range of products and processes, often at very low concentrations within complex matrices. The analytical approach that suits one application will not necessarily suit another. Detection limits, matrix interference and regulatory context all shape the method in different industries.

 

Pharmaceuticals

Pharmaceutical products bring a specific set of nitrosamine challenges. You are often dealing with very low limits, complex formulations and manufacturing routes that can influence impurity formation. Small differences in matrix or process can change the result.

Below, you will find common pharmaceutical scenarios, covering precursor impurities, individual APIs and finished products, along with the analytical considerations that matter in each case.
Reagent-1
Nitrites and Nitrates in Excipients

 

Nitrite and nitrate impurities can act as precursors in nitrosamine formation. If you detect these early, in excipients or raw materials, you reduce the risk of formation later in the process. Screening at this stage helps you address potential issues before formulation and avoid unnecessary batch loss.

This application focuses on screening pharmaceutical excipients for nitrite and nitrate as part of a preventative control strategy.

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Pharma_Blister_Pack
NDMA Contamination in Metformin

 

Metformin products brought renewed attention to nitrosamine control in finished dosage forms. NDMA can form within the product matrix, and regulatory limits are set at very low daily exposure levels. That means your method needs to detect trace contamination reliably, without interference from a high-mass API background.

This application focuses on screening metformin tablets for total nitrosamines, with calculation of NDMA levels against current exposure limits.

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Ranitidine_Bottle
Nitrosamine Analysis in Ranitidine

 

Ranitidine highlighted how nitrosamines can be present in finished products at levels above acceptable daily limits. In this case, NDMA was detected, but the chromatogram also indicated additional nitrosamine-related species within the sample matrix.

This application demonstrates selective detection of nitrosamines in ranitidine using GC-TEA, with emphasis on identifying specific compounds and revealing related species that may not be visible using non-selective methods.

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Sartans_Bottle
Nitrosamine Analysis in Sartans

 

Sartan APIs and finished products have been subject to detailed review for nitrosamine impurities. Manufacturing routes, solvents and reaction conditions can influence the formation of compounds such as NDMA, which must be controlled against strict daily exposure limits.

This application demonstrates selective quantification of nitrosamines in Sartan tablets using GC-TEA, with sensitivity aligned to regulatory thresholds and clear confirmation of compliant levels.

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Food and Beverage

Food and drink production brings its own nitrosamine considerations. You may be dealing with raw materials where formation can occur during processing, particularly where heat and nitrogen-containing compounds are involved. The levels are often low, and the surrounding matrix can make selective detection difficult.

Below, you will find applications focused on measuring specific nitrosamines in food ingredients, with methods suited to complex organic matrices.
Hops_Malting
Analysis of NDMA in Malt

 

NDMA can form in malt during certain processing steps. When you are working with raw materials, even low concentrations matter, especially if that ingredient is used repeatedly or at scale. The analytical difficulty comes from detecting trace NDMA within a complex organic matrix.

This application focuses on selective detection of NDMA in malt, with attention to matrix interference and low-level measurement.

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Materials

Rubber and elastomer products bring a different set of nitrosamine questions. You may be dealing with emissions from finished products, or with residual compounds formed during curing and processing. The matrix is different, but the requirement is the same. You need clear identification at low levels without interference from other volatile species.

Below, you will find applications focused on detecting nitrosamines in rubber and elastomer materials.
Rubber_Toy
Nitrosamines in Rubber and Elastomers

 

Nitrosamines can form during the curing of rubber and elastomer materials, particularly where secondary amines are present. These compounds may be released as emissions or remain within the finished product.

This application focuses on selective detection of nitrosamines in rubber and elastomer samples.

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Environmental and Emerging Applications

Nitrosamines are also relevant in environmental and industrial systems. You may encounter them in process streams, solvent systems or treatment technologies where amines are present. The analytical challenge often involves low concentrations in chemically active matrices.

Below, you will find applications focused on monitoring nitrosamines in emerging industrial contexts.
Carbon_Capture
Nitrosamines in Carbon Capture

 

Amine-based carbon capture systems can generate nitrosamines as degradation products under certain operating conditions. Monitoring these compounds helps you understand solvent stability and potential environmental impact.

This application focuses on detecting nitrosamines in carbon capture solvent systems, with methods suited to reactive and complex process matrices.

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The Instruments Behind These Applications

The applications outlined above use two established analytical approaches. In some cases, you need selective detection of specific nitrosamines. In others, you need broader screening to assess overall risk before taking further action.
Ellutia TEA Thermal Energy Analyser-4

Selective Detection with the Thermal Energy Analyser (TEA)

When you are targeting defined compounds such as NDMA or NDEA, selectivity matters. Complex matrices can contain many co-eluting compounds, and non-selective detection increases the chance of interference.

The Thermal Energy Analyser is used as a detector coupled to a gas chromatograph. The GC provides separation of individual compounds, and the TEA responds specifically to the nitrosamine functional group. Together, this allows clear identification and quantification of individual nitrosamines at low levels.

This approach is commonly used for confirmatory analysis in pharmaceutical and industrial applications.

 
Ellutia Automated Total Nitrosamine Analyser Chemical Stripping-12

Total Nitrosamine Screening with the ATNA

In screening applications, you may not be targeting a single compound. Instead, you need to determine whether nitrosamines are present at all.

The ATNA detects the N=O functional group common to nitrosamines, allowing assessment of total nitrosamine content across a sample. This approach is suited to excipient screening, raw material control and early-stage process monitoring.

Get the Nitrosamine Analysis Buyers Guide

The Buyers Guide explains the available approaches for nitrosamine detection and screening across pharmaceutical, food, material and environmental applications. It outlines when selective detection is required, when total screening is appropriate, and how different system configurations fit into your workflow.

  • Learn when to use selective detection for specific nitrosamines
  • Compare screening and confirmatory approaches for your application
  • Understand system configuration, method considerations, and analytical limits

Download the buyers guide

 

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