By Tim Sandle

Published in: Outsourced Pharma Newsletter May 22, 2024

Published on: May 6, 2024

Nitrosamines (N-nitrosamines) are organic compounds that feature a nitroso group bonded to a deprotonated amine. These mutagenic chemicals pose a concern across food and medicines since most nitrosamines are carcinogenic (in particular, connected to incidences of gastric and esophageal cancers) and several are genotoxic. Seven types of nitrosamines are considered to be potential contaminants of pharmaceutical products: Several regulatory agencies have previously issued guidelines on nitrosamines and pharmaceutical products. The World Health Organization (WHO) has added to the availability of documents with a new draft guidance (April 2024).2

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