Address the global regulatory requirements for the detection and quantification of N-nitrosamine as well as other mutagenic impurities in APIs and final drug products
Mutagenic impurities pose a significant risk, even in trace amounts, as they can interact with DNA, potentially causing a carcinogenic response. Regulatory pressure to detect and quantify mutagenic impurities is increasing. Recently, regulatory agencies like the U.S. Food and Drug Administration and European Medicines Agency detected N-nitrosamine impurities (NDMA, NDEA, NMBA, etc.) in several blood pressure medicines (sartans) as well as in heartburn and stomach ulcers medicines (ranitidine). These findings not only led to drug product recalls and regulatory actions but also the development of specific guidelines for evaluating these mutagenic impurities with limits of detection ranging from ppm to ppb, well below those for other impurities as mentioned in ICH Q3A.
Agilent offers gas and liquid chromatography coupled with high- sensitivity triple quadrupole mass spectrometry and high-resolution quadrupole time-of-flight mass spectrometry for identification and quantitation of nitrosamines in active pharmaceutical ingredients (APIs) and drug products.