Advanced nitrosamine impurities
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.
Advanced Nitrosamine Detection and Risk Assessment
- 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.