---
type: "WebPage"
title: "Nitrosamine Analysis Services"
description: "Your need: identify and quantify nitrosamines in your products Nitrosamines: what are they? Nitrosamines belong to the family of nitrogenous and oxidized chemical compounds.Whether present intentionally or not, nitrosamines are found in a number of industrial products, notably in medicines..."
resource: "https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/"
tags: ["EN", "pll_612746f4ca97d", "Health", "Anaïs DECAUX"]
timestamp: "2026-08-18T09:01:16Z"
published: "2021-08-26T07:47:00Z"
language: "en"
author: "bwa"
---

# Nitrosamine Analysis Services

## Your need: identify and quantify nitrosamines in your products

### Nitrosamines: what are they?

Nitrosamines belong to the family of nitrogenous and oxidized chemical compounds.

Whether present intentionally or not, nitrosamines are found in a number of industrial products, notably in medicines and cosmetic products, but also in the food sector (such as additives) and plastics processing.

Here are some of the nitrosamines most commonly analyzed by FILAB:

### Nitrosamine analysis

non-exhaustive list

  [NDEA (CAS : 55-18-5)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-ndea.md) [NDMA (CAS : 62-75-9)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-ndma.md) [NEIPA (CAS : 16339-04-1)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-neipa.md) [NDIPA (CAS : 601-77-4)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-ndipa.md) [NMBA (CAS : 61445-55-4)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-nmba.md) [NMPA (CAS : 614-00-6)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-nmpa.md) [NDPA (CAS: 621-64-7)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-of-ndpa-2.md) NMPEA (13256-11-6) [NDELA (1116-54-7)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/analysis-of-ndela-according-to-iso-10130.md) NDPh/NDPhA (86-30-6)   [MeNP (CAS : 16339-07-4)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-menp.md) [NMOR (CAS : 59-89-2)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-nmor.md) [NPYR (CAS : 930-55-2)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-npyr.md) [NPIP (CAS : 100-75-4)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-npip.md) [NMEA (CAS : 10595-95-6)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-nmea.md) [NDBA (CAS : 924-16-3)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-ndba.md) NMPH (55557-03-4) NEPhA (612-64-6) NDINA (1207995-62-7)   NDSRI - (nitrosamine impurities derived from the active substance)
## Targeted Analysis of Complex Nitrosamines:

Non-exhaustive list: 1-Nitroso-4-(2hydroxyethil)-piperazine, 2-Nitroso-octahydrocyclopenta[c]pyrrole, 4-Nitroso-Hydrochloroothiazide, N-Nitroso-Paroxetine, N-Nitroso-Zolmitriptan, N-Nitroso Biotin, N-Nitroso-Folic Acid, N-Nitroso-Clonidine, N-Nitroso-Diclofenac, N-Nitroso-Paroxetine, N-Nitroso-Salbutamol, Posaconazole Nitroso-Impurity 1, Posaconazole Nitroso-Impurity 2

[Learn more](https://filab.fr/nos-prestations/analyse/laboratoire-dosage-nitrosamine/analysis-ndsri/)

## FILAB, a laboratory for the analysis and quantification of nitrosamines in industrial products

 ![](https://filab.fr/wp-content/uploads/2026/03/Schema-nitrosamines-2-1024x576.png)
### Our services for nitrosamine analysis and quantification

[Nitrosamine quantification in pharmaceutical products](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-pharmaceutical-nitrosamines.md)

[Elemental impurity analysis (ICH Q3D context)](https://filab.fr/nos-prestations/analyse/laboratoire-analysis-ich-q3d/)

Analyse de nitrosamine par[ATNC](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/nitrosamines-testing-atnc-method.md)

Analyse de nitrosamine par [GC-TEA](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/analysis-nitrosamines-gc-tea.md)

[Validation de méthode analytique selon l'ICH Q2(R2)](https://filab.fr/en/our-services/our-expertise-services/laboratory-analytical-method-validation/validation-of-laboratory-analysis-methods-according-to-the-ich-q2-standard.md)

[Method development](https://filab.fr/en/our-services/our-expertise-services/analytical-development.md) for nitrosamines : validation and transfer of nitrosamine quantification methods

[Nitrosamine quantification in cosmetic products](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/analysis-nitrosamines-cosmetics.md)

[Analyse d’impureté de nitrosamine](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/analysis-nitrosamines-impurities-laboratory.md)

[Analyse nitrite et nitrate](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-determination-nitrites-nitrates.md)

## Our analytical techniques for nitrosamines

 [### LC-MS/MS](https://filab.fr/en/our-services/our-analysis-services/chemical-analysis-laboratory/natural-extract-analysis-in-laboratory.md) [### LC-QTOF](https://filab.fr/en/our-technical-resources/laboratory-for-lc-qtof-analysis.md) [### GC-MS](https://filab.fr/en/our-technical-resources/laboratory-analysis-gcms.md) [### LC-CAD](https://filab.fr/en/our-technical-resources/laboratory-analysis-uplc/analysis-lc-corona-laboratory.md) [### LC-UV](https://filab.fr/en/our-technical-resources/high-pressure-liquid-chromatography-uplc-laboratory.md)   Discover our case study
## Nitrosamines in infusion bags: what does the FDA say and how can you protect against them?

 [Learn more](https://filab.fr/en/blog/2025/12/nitrosamines-in-infusion-bags-what-does-the-fda-say-and-how-can-you-protect-yourself.md)
## Substances classified as hazardous

Nitrosamines have been classified as hazardous substances and potentially carcinogenic to humans by the IARC and the WHO.

They are also monitored by the **ANSM** (French National Agency for Medicines and Health Products Safety), which is currently carrying out more in-depth studies on the risks associated with the presence of nitrosamines in medicines.

The **Food and Drug Administration (FDA)** monitors and regulates the presence of nitrosamines by setting safety limits and providing analytical methods to ensure pharmaceutical product compliance.

In the pharmaceutical industry, there are several possible causes of formation, including:

- the tetrazole ring
- products containing nitrite functions and tertiary or secondary amine functions (ubiquitous in active ingredients)
- the degradation of a tertiary or secondary amine function or a quaternary ammonium salt
- a by-product of water disinfection by chloramination
- the use of raw materials, solvents or catalysts that may degrade into amines.

*Reference to consult: [EMA/170098/2022](https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-questions-answers-marketing-authorisation-holders-applicants-chmp-opinion-article-53-regulation-ec-no-726-2004-referral-nitrosamine-impurities-human-medicinal-products_en.pdf)*

### Assessing product-related risks

When assessing product-related risks, it is essential to prioritize medicines based on the likelihood of nitrosamines being present, as these substances may be non-compliant.

This assessment is based on product formulations, manufacturing processes, and previous test results.

Medicines containing nitrosatable compounds or manufactured with nitrating agents must be rigorously tested and monitored. A structured approach makes it possible to identify high-risk products and implement corrective measures to ensure product compliance.

### Assessing the risk of nitrosamine formation in the product, following processing

  ![laboratoire](https://filab.fr/wp-content/uploads/2025/09/ecovadis-77-e1758270830240.png)
 

The assessment of risks associated with manufacturing processes aims**to identify**and**minimize the potential formation of nitrosamines in products.**

This assessment involves a thorough analysis of the chemical reactions used, raw materials, and manufacturing conditions.

Factors such as the presence of nitrites and amines, pH, and reaction temperature are closely examined to detect risks. Preventive measures, such as raw material control and process optimization, are essential to reduce nitrosamine formation and ensure compliance with safety standards.

## To go further...

To support manufacturers in product development and quality control, while keeping pace with regulatory changes, the laboratory provides state-of-the-art analytical equipment, enabling the quantification of nitrosamines and their precursors at trace levels in all types of matrices (pharmaceutical, cosmetic, polymer, water, food…). In addition, the FILAB laboratory has an excellent understanding of pharmaceutical regulatory texts. 

As an expert pharmaceutical analysis laboratory, we have state-of-the-art analytical equipment and carry out analysis using the [LC-MSMS,](https://filab.fr/nos-moyens-techniques/laboratoire-analysis-chromatographie-liquide-hplc/laboratoire-analysis-hplc-ms/) [GC-MS](https://filab.fr/nos-moyens-techniques/laboratoire-analysis-chromatographie-gc-ms/) or [GC-MS/MS](https://filab.fr/en/our-technical-resources/gc-msms-analysis-laboratory.md) techniques, as well as [LC-UV](https://filab.fr/nos-moyens-techniques/laboratoire-analysis-chromatographie-liquide-hplc/laboratoire-analysis-hplc-uv/). 

The detection limits for nitrosamine quantification range from 1 to 10 µg/kg (ppb), depending on the nitrosamines and the type of matrix.

The FILAB laboratory analyzes [nitrosamines in cosmetics according to ISO 14735](https://filab.fr/secteur-activite/analyse-cosmetique/analysis-cosmetiques-iso-14735/).

**The FILAB laboratory also has a COFRAC-validated method for the quantification of certain nitrosamines by LC-MSMS within the framework of [ISO 10993-18](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-material-chemical-characterization.md).**

## Our FAQ

 What are the main issues linked to the presence of nitrosamines in industrial products?
Nitrosamines are potentially carcinogenic compounds found in various industrial products such as food, plastics, and pharmaceutical products. Their detection and elimination are crucial to protect consumer health and comply with current regulations.

 Why do nitrosamines pose a specific problem in materials and plastics?
In materials and plastics, nitrosamines can form during manufacturing processes, particularly in rubber products. Their presence can contaminate packaged products and pose health risks, making analysis essential to ensure safety.

 What are the specific issues of nitrosamines in the cosmetics and pharmaceutical sectors?
Cosmetic and pharmaceutical products are applied directly to the skin or ingested, which increases the risks associated with the presence of nitrosamines. Strict regulations require in-depth analysis to detect and eliminate these compounds, ensuring user safety.

 How can the food industry manage the risk of nitrosamines?
The food industry must monitor potential sources of nitrosamines, such as nitrite preservatives. Regular and rigorous analysis are necessary to ensure products comply with food safety standards and minimize risks for consumers.

 Why use a laboratory like Filab for nitrosamine analysis?
Filab has the expertise and advanced technologies needed to detect and quantify nitrosamines accurately. Working with a specialized laboratory enables companies to comply with regulations, ensure product safety, and protect consumer health.