ANVISA's guide document on Nitrosamine NEW!

I want to share the newly published guidance from ANVISA on the Control of Nitrosamines in APIs and Medicines. Any interest from our community members to organize a Q&A session with some of the Brazil members to introduce the guide details?
I personally find interesting these on the guidance:

  • 3 phase approach (Risk Assessment, Confirmatory testing and Process changes)
  • Specific expectations regarding risk assessment (334-344)
  • Section dedicated to Applicability of ‘Purge’ concept in line with ICH M7 option 4 (356-359)
  • Referenced used for “Purge” factor calculations @AndyTeasdale @MichaelBurns
  • API supplier testing of Nitrosamine DOES NOT exempt the need for risk assessment in the finished product (417-421)
  • Guideline on number of batched to be tested based upon risk assessment (424)
  • Use of limits based on the concept of TTC is not applicable
  • Limits cited in the guidance for NDMA / NDEA / EIPNA / DIPNA / NMBA / MeNP / NDBA / NMPA
  • Some limits were established based on (Q)SAR and consider ‘interim limits’
  • Two case scenarios when more than one nitrosamine is present (493)
  • Approach to derive limits to new nitrosamines, reference to " Utilisation of parametric methods to improve percentile-based estimates for the carcinogenic potency of nitrosamines" –Link– @David
  • Concept of LTL approach @jbercu

(1)Guia_50_Nitrosaminas_rev_final_para publicação (1).pdf (1.0 MB)


Lhasa Limited are actually putting on a free workshop next week, alongside ANVISA and industry speakers from Brazil and beyond, looking at this guidance and its impact - with plenty of time for Q&A!


@David Thanks for sharing the event details. In a previous exchange with Andy, he suggested including Sindusfarma and Interfarma for a perspective discussion. Any interest in planning that together? Adding my USP colleagues from Brazil here @LucianaT @AmandaGuiraldelli


It is possible to get English version of this Nitrosamine guideline , thans in advance

I add the link of ANVISA’s presentation slide and recording in 2021 Webinar | Lhasa Limited Nitrosamine Impurity Workshop. Q&A is not included here, however it may take time to disclose English ver.


@Yosukemino Thanks for sharing the recording of the session

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Can I get english version of attached guidelines.