👨‍💻 Dashboard Containing Published AI Limits

I would like get clarification whether I can report the Nitrosamine content in terms of ng/Tablet. If so what would be the exact formula??

The dashboard has been updated with EMA’s July 1st update.

-link in the post initial post-


Hi Naiffer … EMA has been published limit for Nitroso-tigecycline as can be controlled as per ICH Q3B. Can this limit applied for US scope (Tigecycline).

Hi, Any specific reason why there is different AI published by US FDA and rest of the authorities? Eg Sertraline US FDA has AI:100 and rest of the authorities 1500.

Dr. Jayvant H
Cipla Ltd, India

@romnaiffer : There seems to be differences between Dashboard 1 and 2. E.g. entry for N-Nitroso-Palbociclib
Dashboard 1 400 [remowed]
Dashboard 2 400
Is the database behind those two different dashboards different?