Helping you ensure pharmaceutical product safety of your elastomeric components with our expert Nitrosamine Testing services.
Element supports all requirements for Nitrosamines testing of elastomers and other polymeric materials for use in pharmaceutical products. We're committed to delivering the critical Nitrosamine impurity data you need to achieve regulatory approval and remain compliant.
Whether your pharmaceutical product is approved, marketed, or under review, we'll deliver the data you need to achieve regulatory approval, support application changes, and stay on market.
With a demonstrated history of success testing for Nitrosamine impurities, we’ll help you satisfy regulators with robust method development, validation, and testing to detect Nitrosamines at low parts per billion (ppb) levels of detection.
The benefits of choosing Element for your Nitrosamine impurities analysis
- Identify and quantify Nitrosamine impurities in pharmaceutical products
- Ensure compliance with US FDA, EMA and Health Canada requirements
- Maintain patient safety and efficacy of drug products
- Rapid turnaround times to support the timely launch of products to market
- Access advanced instrumentation and expert problem-solving capabilities
- Overcome all analytical challenges with robust and validated test methods
- Instil confidence with accurate, dependable results that you can trust
Our Services and Capabilities
We have developed and fully validated robust test methods available for the trace level determination and quantitation of N-nitrosamines in elastomers (see table below).
You’ll experience seamless integration with your team - Element's experienced scientists with a wealth of knowledge will provide dedicated support. Together, we'll assess the risk of Nitrosamine contamination to; deliver accurate, high-quality data on your timeline.
Our industry leading laboratories ensure swift turnaround times without compromising accuracy, offering comprehensive analytical solutions for every challenge.
With expert problem-solving capabilities and a commitment to regulatory compliance, coupled with access to advanced instrumentation, we support pharmaceutical companies to navigate complex testing requirements seamlessly.
Explore a partnership with Element for Nitrosamines Testing
If you want to connect with our team to discuss how Element can help you meet regulatory expectations, click the orange button. Our team are ready to support you analytical testing needs today!
The danger of Nitrosamine impurities in pharma products
Highlighted as potential carcinogens, a number of N-nitrosamine compounds are included in the USP <1381> and <1664.1> monographs as Special Case Compounds which, as potential leachables in drug products, may require additional specific characterisation of elastomeric components to ensure overall patient safety.
Contact Element today
When you partner with Element, you'll get the personalized attention and support you deserve from leading scientific experts at the forefront of evolving regulations.
Contact our team today to discuss any requirements for N-nitrosamine testing including analysis of additional polymer materials and / or N-nitrosamines and to learn more about how Element's Rapid Response services can elevate your analytical capabilities to new heights.
For more information about our Life Sciences, discover our team of experts, read our latest thought leadership content, or contact us today.
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Welcome to Element Manchester
Our Manchester laboratory is home to over 50 life science experts dedicated to helping our clients ensure patient safety.
We bring cutting-edge extractable & leachable techniques, state-of-the-art equipment, and knowledge of regulatory standards to provide high quality analytical data to help you make key decisions on your product.
Life Sciences Content
Check out our Life Sciences thought leadership content including webinars, white papers, case studies blogs and more.
Written by our industry experts, we tackle a range of subjects across Antimicrobial, Biotechnology Food, Medical Device, Pharmaceutical, and Personal Care industries.
With a commitment to absolute certainty, we utilize our extensive expertise and experience to provide insights that ensure the safety of materials used in the life science sector.
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