PANEL: Successful Mitigation Strategies for Nitrosamines

PANEL: Successful Mitigation Strategies for Nitrosamines

Online
Panel Discussion

Information

Nitrosamine contamination in the context of increased regulatory assessments for marketed products and new drug applications

Nitrosamine remediation: which way to go – low-nitrite excipients or addition of scavengers?

Debating the recent challenges related to N-nitrosodimethylamine (NDMA) contamination and N-Nitrosamine drug substance-related impurities (NDSRIs). Nitrites in excipients leading to nitrosamine formation in drug product

An update on the latest guidelines on nitrosamine risk evaluation and risk assessment. On the path to international regulatory harmonisation


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