Guidance on Nitrosamine Impurities from Health Canada

Guidance, Documents, Resources
1

Effective April 2022, enclosed is the guidance document from Health Canada

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2

This is now obsolete. Download the May 2022 version instead.

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3

Thank you very much @kpcross .

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4

I have updated the post to contain only the most up-to-date version. Thanks @kpcross

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5

Thank you for sharing the information, @kpcross. I converted the PDF of the latest guidance (May 2022 version) and the previous one (April 2022 version) into word format and compared each other. The difference was only the limit of NNORT and NMPEA. It changed to 8.0 from 8.00. It looks like a minor update. :grinning:

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6

They added new limits for additional nitrosamines that were not listed before

7

I clarified the version of the guidance in the previous post. Thank you.

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