US EditionDrug Substance and Drug Product Workflows for Quality Risk Management for the Presence of Nitrosamines in Medicines - Pharma Excipients
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Drug Substance and Drug Product Workflows for Quality Risk Management for the Presence of Nitrosamines in Medicines - Pharma Excipients
Abstract The ICH M7 guidance “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” requires that drug substances and drug products be assessed for potential mutagens including N-nitroso compounds. N–Nitrosamines are a class of N-nitroso compounds within the cohort of concern as defined in ICH M7 because they can display carcinogenic potency with acceptable intakes in the range of …
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