The Column - Digital Edition - 09/06/2012
The Need For Speed
Free Poster: NDSRI Risk Assessment and Trace-Level Analysis of N-Nitrosamines
April 25th 2025With 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.
New Guide: Characterising Impurity Standards – What Defines “Good Enough?”
April 25th 2025Impurity 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.
Using the Carcinogenic Potency Categorisation Approach (CPCA) to Classify N-nitrosamine Impurities
April 25th 2025Learn 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.
