Nitrosamines Published Limits -reference

Limits of Nitrosamines
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@pragnesh
Thanks for sharing this information

@Naiffer_Host @pragnesh @Yosukemino @jxl @Sarada.jena @Rafa
Dear Team,
Moreover, as per recent updated guidance’s regarding Nitrosamine impurities, 3 new Nitrosamine AI limit has been published.

  1. 4-(methylnitrosamino)-1-(3-pyridyl)-1-(butanone) (NNK) - 100ng/day
  2. N-nitroso-dabigatran- 18.0 ng/day
  3. N-nitroso-tamsulosin- 18.0 ng/day

guidance-nitrosamine-impurities-medications-eng.pdf (canada.ca)

However, 4-(methylnitrosamino)-1-(3-pyridyl)-1-(butanone) (NNK) is new Nitrosamine Impurity AI limit is published in Health Canada guidance’s only.

N-nitroso-dabigatran impurity AI limit is published in EMA & Health Canada guidance’s only, having same 18.0 ng/day AI limit.

N-nitroso-tamsulosin AI limit is published in TGA & Health Canada guidance’s only, having same 18.0 ng/day AI limit.

Thanks
Nilesh

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