Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product N-Nitrosamine Impurities
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DOI: 10.1021/acs.chemrestox.1c00369
Abstract: The potential for N-nitrosamine impurities in pharmaceutical products presents a challenge for the quality management of medicinal products. N-Nitrosamines are considered cohort-of-concern compounds due to the potent carcinogenicity of many of the structurally simple chemicals… read more here.
Keywords: nitrosamine; drug product; practical science; nitrosamine impurities ... See more keywords