Precision testing to safeguard your product and patients

Nitrosamine impurities are not merely a regulatory hurdle. They’re a serious patient safety concern. Their presence in pharmaceutical products and APIs can have genotoxic and carcinogenic implications. For manufacturers, identifying the risk, understanding the mechanisms of formation, and mitigating their presence require deep scientific expertise, specialist interpretation, and cutting-edge instrumentation.

The Eurofins BioPharma Product Testing (BPT) network of laboratories offers precisely that. We have become the expert partner of choice for many pharmaceutical manufacturers. Why? Because our advanced analytical capabilities, comprehensive understanding of global regulatory expectations, and track record of delivering results meet the highest international standards.

Our nitrosamine testing and investigation process consists of three key steps built around the requirements of ICH M7:

Step 1 - Risk Assessment: Through gaining more knowledge of the manufacturing process, the nitrosamine presence/formation risk is investigated for each product.

Step 2 - Confirmatory Testing: Sensitive and appropriately validated analytical methods confirm nitrosamine presence/amount.

Step 3 - Remediation Plan: Modifications within the process are identified and applied to mitigate nitrosamine formation risk.

We also support remediation plans with actionable insight and practical testing solutions, while our global network ensures consistent service delivery and data integrity across regions.

With extensive experience in genotoxic impurity testing, our highly trained scientists are well-positioned to support change control assessments and assist with filing responses. Whether you need batch release testing or support during regulatory submission, we’re ready to act with the scientific credibility and responsiveness you so vitally need.

Precision detection. Regulatory confidence. Proven expertise.

Using advanced LC-MS/MS methodologies, our team detects nitrosamines at trace levels, enabling you to meet Health Canada and global regulatory expectations with robust, defensible data.

We support both routine testing and investigative studies across a wide range of APIs and finished pharmaceutical products, helping you proactively manage risk throughout the product lifecycle.

Comprehensive nitrosamine coverage

We test for a wide range of commonly regulated nitrosamines, including:

  • NDMA (N-nitrosodimethylamine)
  • NDEA (N-nitrosodiethylamine)
  • NEIPA (N-nitrosoethylisopropylamine)
  • NDIPA (N-nitrosodiisopropylamine)
  • NDBA (N-nitrosodibutylamine)
  • NMBA (N-nitroso-N-methyl-4-aminobutyric acid)
  • MNP (1-methyl-4-nitrosopiperazine)  

We also develop and validate methods for additional or emerging nitrosamine impurities, ensuring your testing strategy remains aligned with evolving regulatory requirements.

Support for high-risk products and regulatory focus areas

Health authorities have identified several drug classes as higher risk for nitrosamine contamination, including:

  • Metformin
  • Ranitidine and nizatidine
  • Rifampin and rifapentine
  • Sartans (e.g., valsartan, losartan, irbesartan)
  • Varenicline and other small molecule drugs

Our team brings deep experience testing these products, helping you address regulatory expectations efficiently and proactively.

End-to-end support for nitrosamine risk management 

We go beyond testing to support your full compliance strategy. Our services include:

  • Method development, validation, and transfer
  • Confirmatory testing and routine batch release support
  • Risk assessment and investigation support
  • Adaptation to evolving global guidelines

A partner who helps you stay ahead of regulatory change 

You need a testing partner who understands the urgency, complexity, and regulatory pressure surrounding nitrosamines. Our experts work closely with you to:

  • Minimise risk of non-compliance or product recalls
  • Generate accurate, trace-level data with confidence
  • Adapt quickly to new regulatory guidance
  • Maintain supply continuity and protect patient safety

Get in touch

With deep analytical expertise and advanced instrumentation, our experts partner to reduce risk, and safeguard your products at every stage.

Contact us

Advanced Nitrosamine Detection and Risk Assessment

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Nitrosamine testing services

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  • Specialised method development and validation for ultra-trace levels of nitrosamines in APIs, drug products, and complex matrices under GMP conditions; choice of suitable analytical methods depends on the risks identified, the formulation and the nitrosamine(s) to be measured.
  • Detection of nitrosating agents using specifically developed methods to measure nitrite ions in your intermediates, excipients, and production media. This enables appropriate measures to be taken to control the risk of formation of nitrosamines.
  • Use of high-end instrumentation including LC-MS/MS, GC-MS, and HRMS to achieve the necessary levels of sensitivity. The quantification limits are in the PPB range, in line with the acceptable limits described in ICH M7.
  • Comprehensive risk assessments that evaluate formulation, synthesis pathways, and packaging to pinpoint potential formation mechanisms.
  • Routine testing with short turnaround times (TATs) for high-volume or time-sensitive batches.
  • Support in sourcing or qualifying reference standards whether at the screening stage or the assay stage, the availability of reference substances can be a challenge and sometimes custom synthesis is required, with appropriate qualification.