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Canada HC Guidance: Nitrosamine Impurities in Medications

Last Friday (28 July, 2023) Health Canada published an updated "Guidance on Nitrosamine Impurities in Medications" that details about Evaluating and managing the risks of N-nitrosamine impurities in human pharmaceutical, biological, and radiopharmaceutical products.

Health Canada's recommendations and considerations regarding N-nitrosamine impurities (also known as nitrosamine impurities or nitrosamines) are outlined in this guidance.


Nitrosamines are chemical compounds that have been identified as potential carcinogens and can unintentionally form in some medications during the production process. The presence of nitrosamine impurities in medications has prompted health authorities worldwide to investigate and implement robust measures to minimize patient exposure.


All non-prescription products with a DIN, such as topical antiseptic products, grooming and personal hygiene products and sunscreens, are within the scope of products for assessment if they contain a chemically synthesized or semi-synthetic API.


The request for conducting risk assessments for the potential presence of nitrosamine impurities was extended to all biological and radiopharmaceutical products for human use. This was outlined in Health Canada's letter dated December 15, 2020.


Manufacturers are required to perform risk assessments and take appropriate measures to control the potential for nitrosamine formation, such as using alternative manufacturing processes, sourcing materials from different suppliers, and conducting additional testing.


To know more in detail about determining the priorities and order in which products should be reviewed, and important questions & answers related to Nitrosamine Impurities, click this LINK.

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