Ensuring the safety of patients and the integrity of your pharmaceutical product hinges on identifying and controlling elemental impurities. Whether it’s an API or a finished product, even trace levels of heavy metals can pose serious health risks and put regulatory compliance at risk.

The Eurofins BioPharma Product Testing (BPT) network of laboratories offers advanced trace metals testing that supports both risk assessment and GMP quality control, helping you meet the demands of USP <232>/<233>, ICH Q3D, and other global guidelines.

We understand the complexity of testing requirements

Because choosing between general screening and specific element analysis, determining the right instrumentation, and validating methods can be challenging, our scientific experts will collaborate with you to tailor an approach that balances time, cost, and compliance.

Cutting-Edge Laboratories

We offer both validated and non-validated testing services to help you navigate trade-offs based on your product’s lifecycle stage and regulatory objectives. Our laboratories possess various capabilities such as high-performance ICP-MS, ICP-OES, Flame AA, Graphite Furnace AA, and Cold Vapor AA (mercury and arsenic), enabling simultaneous multi-element analysis with exceptional sensitivity and accuracy, even down to  parts-per-billion levels.

Key advantages of our elemental impurities testing include:

• Testing aligned with USP <232>/<233> and ICH Q3D
• Rapid, multi-element detection
• Support for method validation or custom method development
• Strategic input for risk-based approaches and quality strategies

The BPT metals team has the expertise to troubleshoot complex sample matrices and method challenges, including onboarding silicone oil testing in antifoam/simethicone matrices.  

Our on-site pharmacopeia liaison will contact USP and Ph. Eur. for clarification. Whether a non-GMP general screening method, or a validated GMP analysis to withstand regulatory review, our regulatory experience enables us to ask the right questions at the right time and determine the most appropriate testing approach to meet your needs.

With our transparent reporting systems, fast turnaround times, and global network of regulatory-savvy scientists, with Eurofins BPT you can be confident elemental impurities won’t delay development or compromise compliance.