Case study: GC-MS for cGMP nitrosamine testing
What pharmaceutical QA/QC laboratories need to know to overcome the challenges of nitrosamine impurities in drugs for cGMP testing.
The low levels at which the nitrosamine impurities could be present in pharmaceutical products pose challenges for analytical laboratories. The limits imposed by regulations are strict and could potentially be lowered to ensure patients safety. Single quadrupole ISQ 7000 GC-MS and triple quadrupole TSQ 9000 GC-MS/MS systems are compliance-ready with FDA regulation, meeting, often exceeding the method requirements and providing the sensitivity, selectivity and precision needed for reliable quantitative analysis of these impurities.
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Analytical techniques, Biologics, Biopharmaceuticals, Chromatography, Data integrity, Drug Delivery Systems, Excipients, Formulation, Good Manufacturing Practice (GMP), Ingredients, Lab Automation, Manufacturing, Mass Spectrometry, Outsourcing, QA/QC, Regulation & Legislation, Research & Development (R&D)