thanks a lot for the input!
@Naiffer_Host me apunto para participar en la convocatoria, en cada paso que se da surge una nueva pregunta.
Very useful summary.
Is there a link where I can see the discussion you have with Cofepris. It will be very useful. Thanks!
dear @Naiffer_Host
in “APÉNDICE 2” for “LÍMITES DE IA O DE SEGURIDAD PARA IMPUREZAS DE NITROSAMINAS” as published in 2024, the Nitrosamine of Sitagliptin is reported twice with different AIs (ie 37ng/d and 100ng/d)
Could you please clarify or you consider this to be revised in next update? Should we consider AI 100ng/d as the valid one?
Dear Eleni,
I would consider 100 ng/day since it is the official CPCA threshold
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Is it correct that this announced version 2.0 is not yet available?
(Since the July 2024 guidance publication only Appendix 2 updated in December 2024?)
Do we perhaps know when we can expect this guidance update?
Does anyone have experience with the flexibility from above Q&A being actively applied in current practice?
The V2 of the guide has not been issued just yet. I can confirm the agency is currently working on the revision.
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