Factsheet Download: Nitrosamine Analysis in Medicines
NITROSAMINE IMPURITY ANALYSIS (NDMA, NDEA, NDIPA AND NMBA) IN MEDICINES
Detection and quantification of nitrosamine impurities using GC-MS and LC-MS Methods
There is a current focus by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory bodies on nitrosamine impurities as these have been found in some angiotensin II receptor blocker (ARB) medicines, such as valsartan, and more recently in histamine-2 receptor blocker medicines, such as ranitidine. Robust analysis to determine if these impurities are present and at what levels is critical to ensure these potentially harmful impurities do not enter the market in the future.
Our experts detect and quantify nitrosamine impurities in APIs and finished drug products. Data can be used to support regulatory submissions or quality assessments.
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