Nitrosamine Analysis Services
What are Nitrosamines?
Nitrosamines belong to a group of nitrogenous and oxidized chemical compounds. They are the result of a combination of nitrites or nitrates with meat proteins.
Whether or not they are meant to be present, nitrosamines can be found in a wide variety of industrial substances, mainly in food production (used as additives), in plastics engineering, in cometic products and even in some medications (solvents).
These are a few examples of nitrosamines:
FILAB, an analytical laboratory capable of determining the nitrosamine contents of industrial products
Our services for the analysis and dosage of nitrosamines
The FILAB laboratory also has a method validated by COFRAC for the determination of certain nitrosamines by LC-MSMS within the framework of the ISO 10993-18 standard.
Substances classified as being dangerous
Nitrosamines were classified as dangerous and potentially carcinogenic substances 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 conducting 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 establishing safety limits and providing analytical methods to ensure compliance of pharmaceutical products.
Nitrosamine laboratory expertise & capabilities
Your expert nitrosamine laboratory – FILAB
FILAB stands out as your dedicated nitrosamine laboratory, offering comprehensive analytical and regulatory services tailored to the pharmaceutical industry’s stringent requirements.
What sets our nitrosamine laboratory apart:
- Full-spectrum nitrosamine testing
Execute the complete analysis cycle—from screening to quantification—for NDMA, NDEA, NDPA, and a broad range of nitrosamine contaminants. - Tailored method development & validation
At our nitrosamine lab, we customize methods specific to your product matrices—be it APIs, intermediates, excipients, or drug formulations. We guarantee validation parameters such as sensitivity (LoD/LoQ), specificity, and precision. - Integrated analytical techniques
Leverage advanced instrumentation including LC-MS/MS, GC-MS/MS, HRMS, and ultra-sensitive workflows—all under controlled conditions in our specialized nitrosamine laboratory. - Regulatory-ready compliance
Ensure compliance with regulatory nitrosamine thresholds with our validated testing strategies.. Receive laboratory-grade, audit-friendly data to support your dossier and risk assessments.
Laboratory infrastructure & process control
State-of-the-art nitrosamine laboratory infrastructure
Our laboratory is designed to deliver high confidence test results, even at ultra-trace levels:
- Proven sample preparation protocols: optimized extraction and clean-up routines ensure the integrity of nitrosamine measurements, minimizing matrix interferences—critical in a nitrosamine laboratory environment.
- Dedicated analytical zones: purpose-designed spaces minimize cross-contamination and streamline sample processing, ensuring accuracy and efficiency in the nitrosamine laboratory workflow.
- High-sensitivity mass spectrometry workflows: employing triple-quadrupole and high-resolution mass spectrometers (HRMS) for superior selectivity, even within complex matrices—standard in our nitrosamine laboratory.
- Inter-laboratory comparability and certification: developed methods are regularly benchmarked with peer labs to verify robustness and reproducibility—ensuring your results meet regulatory expectations for a certified nitrosamine laboratory.
Why choose FILAB as your nitrosamine laboratory?
FILAB – Your preferred partner for nitrosamine analysis
ISO 17025 accredited : your assurance of quality and recognized testing expertise in the nitrosamine laboratory domain.
Trusted by pharmaceutical firms: our specialized nitrosamine laboratory supports both emerging and established players in maintaining product safety and regulatory compliance.
End-to-end service : from risk assessment to corrective actions, our lab provides an integrated approach to nitrosamine control.
Ultra-trace detection & regulatory compliance
FILAB provides comprehensive laboratory testing services for nitrosamine impurities, from initial screening to ultra-trace quantification (ppb level), using state-of-the-art analytical technologies such as LC-MS/MS, GC-MS/MS and HRMS.
Why are nitrosamines a critical concern?
Nitrosamines are chemical compounds classified as probable human carcinogens. They can form unintentionally during manufacturing processes, through interactions between amines and nitrites, or from raw materials, solvents, excipients, or packaging components.
Detecting these impurities requires highly sensitive and highly selective analytical techniques capable of measuring trace concentrations in complex matrices.
FAQ
A nitrosamine laboratory is equipped and validated specifically for ultra-trace analysis of nitrosamines, with dedicated workflows, contamination control zones, and highly sensitive instruments.
Our laboratory can detect NDMA, NDEA, NDPA, NDIPA, NMBA, and additional nitrosamine derivatives, using validated methods across LC-MS/MS and GC-MS/MS platforms.
Through validated sample prep protocols, high-sensitivity instruments, and rigorous matrix interference control within our dedicated nitrosamine laboratory.
Nitrosamines are chemical impurities that may form during manufacturing or storage and are considered potentially carcinogenic.
Regulatory limits are extremely low and may require detection at parts-per-billion (ppb) levels or lower.
We analyze APIs, finished pharmaceutical products, excipients, raw materials, packaging materials, medical devices, and cosmetic products.
Yes. Using high-resolution mass spectrometry, we can screen and identify unknown or unexpected nitrosamine compounds.
Yes. We develop and validate analytical methods according to international regulatory guidelines.
Turnaround time depends on the complexity of the matrix and scope of analysis. Rapid screening solutions are available upon request.
