Tips for Ensuring Data Integrity within a Regulated GXP Laboratory

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.

Polysome profiling is a method for analysing the translational status of cells. This AppNote describes a simple FPLC system for polysome fractionation.

Pfizer streamlined their LC/UV/MS data processing by adopting a semi-automated workflow with MS Workbook Suite, enabling faster, more consistent analysis and cutting process