You would like to analyze and measure NDMA (CAS: 62-75-9) in your product?
What is NDMA?
NDMA (N-nitrosodimethylamine) is a molecule belonging to the nitrosamine family.
Widespread molecules present in many natural or synthetic products, nitrosamines are found in a number of industrial products, particularly in the food industry (as additives), the plastics industry, cosmetics, or even certain drugs (solvents).
NDMA: a chemical compound classified as a hazardous substance
NDMA, like all nitrosamines, has been classified as a hazardous and potentially carcinogenic substance for humans by the IARC and the WHO.
Its presence in health products can result from various chemical interactions during the manufacturing process, particularly between amines and nitrites, or originate from raw materials, solvents, and even packaging components.
Regulatory requirements and monitoring
Nitrosamines are strictly monitored by authorities such as the ANSM (Agence nationale de sécurité du médicament et des produits de santé), which conducts further studies on the risks associated with the presence of nitrosamines in medicines.
FILAB, laboratory for the analysis and determination of NDMA in industrial products
Our analytical solutions for NDMA quantification
To address the challenges posed by detecting NDMA in complex matrices, FILAB utilizes state-of-the-art analytical technologies offering extreme sensitivity and selectivity. Our experts implement advanced methods such as LC-MS/MS (Liquid Chromatography coupled with tandem Mass Spectrometry), GC-MS/MS, or HRMS (High-Resolution Mass Spectrometry). These techniques allow for detection and quantification at the parts-per-billion (ppb) level, ensuring full compliance with the most stringent regulatory requirements.
Expertise across all industrial matrices
To support manufacturers in the development and quality control of their products, FILAB provides advanced equipment enabling NDMA and its precursors to be determined at trace levels in all types of matrices:
Method development and validation (ICH Q2)
Reliability of results is essential for your regulatory dossiers. FILAB can develop specific methods or validate existing methods in strict accordance with international ICH Q2 guidelines and USP standards. Our validation protocols cover the repeatability, precision, linearity, and robustness required for your submissions to the FDA or EMA.
our other analytical services
Method development for nitrosamines: validation and transfer of a nitrosamine assay method
Our FAQ
To obtain a quote, you can contact our team via our contact form, by phone, or by email.
Simply tell us your requirements (type of material, desired analysis, applicable standards, urgency, quantity of samples, etc.). We will then send you a personalized technical and pricing proposal within 24-48 hours.
NDMA analysis is a laboratory testing process used to accurately detect and quantify N-Nitrosodimethylamine, a potentially carcinogenic impurity, in materials, chemicals, or finished products.
Detection limits typically vary from 1 to 10 µg/kg (ppb) depending on the type of matrix and the analytical objective.
Testing is essential for active pharmaceutical ingredients (APIs), finished drug products, excipients, and packaging materials to ensure patient safety.
Yes, using high-resolution mass spectrometry (HRMS), we can screen for and identify unknown or unexpected nitrosamine compounds.
Turnaround times vary depending on the nature of the analysis and the complexity of the expert assessment project.
However, FILAB is committed to providing fast turnaround times tailored to your industrial constraints and urgent needs.
