LGC Standards

Learn how biomarkers, Organ on a Chip Models models and PBPK tools improve toxicity and DDI prediction, cut false positives, and support clearer, ICH M12-aligned decision-making.

With increasing concern over genotoxic nitrosamine contaminants, regulatory bodies like the FDA and EMA have introduced strict guidelines following several high-profile drug recalls. This poster showcases a case study where LGC and Waters developed a UPLC/MS/MS method for quantifying trace levels of N-nitroso-sertraline in sertraline using Waters mass spectrometry and LGC reference standards.

We’ve expanded our capabilities with a state-of-the-art, 200,000 sq ft TRC facility in Toronto, completed in 2024 and staffed by over 100 PhD- and MSc-level scientists. This investment enables the development of more innovative compounds, a broader catalogue and custom offering, and streamlined operations for faster delivery. • Our extensive range of over 100,000 high-quality research chemicals—including APIs, metabolites, and impurities in both native and stable isotope-labelled forms—provides essential tools for uncovering molecular disease mechanisms and exploring new opportunities for therapeutic intervention.

Impurity reference standards (IRSs) are essential for accurately identifying and quantifying impurities in pharmaceutical development and manufacturing. Yet, with limited regulatory guidance on how much characterisation is truly required for different applications, selecting the right standard can be challenging. To help, LGC has developed a new interactive multimedia guide, packed with expert insights to support your decision-making and give you greater confidence when choosing the right IRS for your specific needs.

Learn how to manage nitrosamine impurities in pharmaceuticals with our free infographic. Discover how the CPCA approach establishes acceptable intake limits and guides the selection of NDSRI reference samples. Stay compliant and ensure safety with our ISO-accredited standards.

When high-quality, cost-effective impurity reference standards are unavailable, RRFs provide a practical alternative for impurity quantification.

Webinar Date/Time: Thursday, February 20, 2025 8am PST | 11am EST | 4pm GMT | 5pm CET

In this poster, we explore parameters that could impact data integrity with the analytes in EPA Method 1633, UCMR 5 and the EU Drinking Water Directive regulations.

It is essential to understand the pharmacokinetic profiles and toxicological concerns associated with substances/compounds produced into reference standards trusted for analytical testing and development of high quality pharmaceutical therapies.