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Quality requirements for tobacco - tobacco-specific nitrosamines

Published: June 8, 2023

Here, Dave Elder explores proposals for new FDA rules on tobacco product manufacturing and the concerns around tobacco-specific nitrosamines.

Source: europeanpharmaceuticalreview.com

Related Topics:

United KingdomEl KarnbaneDave ElderAlami ChentoufiBritish Pharmacopoeia Expert Advisory GroupAnalytical Division CouncilDrug AdministrationCommittee For Medicinal Products Human UseAnalysis GroupAnnouncements On Nitrosamine In Varenicline ChantixTobacco Products DirectiveEuropean PharmacopoeiaDivision CouncilJoint Pharmaceutical Analysis GroupDrug UseYoung PeopleMember StatesNew RequirementsTobacco Product ManufacturingMsci WorldDitartrate DihydrateMainstream SmokeChem ResMedicinal ProductsHuman Use

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

Related Topics:

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