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NITROSAMINES: Where now?

Published: February 28, 2023

Here, Dave Elder reflects on the three main instances of nitrosamine contamination as impurities in drug products.

Source: europeanpharmaceuticalreview.com

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United KingdomDave ElderKenyonm KalgutkarStakeholder ForumNonclinical Evaluation For Anticancer PharmaceuticalsBritish Pharmacopoeia Expert Advisory GroupAnalysis GroupDrug AdministrationAnalytical Division CouncilChemspider ReferenceLhasa Cancer Potency DatabaseDivision CouncilJoint Pharmaceutical Analysis GroupRoot CauseRanitidine Hydrochloride Drug SubstancesAssociated DrugNitrite Excipient DatabaseSupportn Nitrosamine Risk AssessmentsEurj PharmDrug EvaluationN Nitroso Compound FormationSecondary AminesOrg Proc ResStatistical ValidationExpert Derived Structure