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    Nitrosamines in pharmaceuticals: Scientific and regulatory status

    Nitrosamines in pharmaceuticals have been of special concern since their presence at unacceptable levels in popular medicines was highlighted in 2018. Since then, improved understanding of their chemistry has enhanced the risk assessments, testing, and mitigation steps required to help minimize nitrosamine contamination in drug substances, excipients, and drug products. In addition, regulatory authorities have largely harmonized requirements and allowable limits in their r...