Strategies for Assessing Acceptable Intakes for Novel N-Nitrosamines Derived from Active Pharmaceutical Ingredients.
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DOI: 10.1021/acs.jmedchem.2c01498
Abstract: The detection of N-nitrosamines, derived from solvents and reagents and, on occasion, the active pharmaceutical ingredient (API) at higher than acceptable levels in drug products, has led regulators to request a detailed review for their… read more here.
Keywords: acceptable intakes; assessing acceptable; strategies assessing; nitrosamines derived ... See more keywords