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-
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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.
Thanks
Dr. Jayvant H
Cipla Ltd, India
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@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?
Is N-nitroso-meglumine small mass nitrosamine ?
Thank you and great initiative.
Hi Dr. Jayvant,
On July 26th Health Canada updated their AI limits for few nitrosamines. https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities/established-acceptable-intake-limits.html#app1
The AI limit for N-Nitroso Sertraline has been revised to 100 ng/day from 1500 ng/day. The reason for revision is not mentioned. The earlier limit of 1500 ng/day was set based on negative result in the in vitro bacterial mutagenicity assay. I can only guess that the in vitro assay data may have been deemed invalid due to some reason and the agency has gone back to CPCA derived limit for this impurity. This is the first instance I have noted a reduction in AI limit. This may have a severe impact on MAH’s who have already submitted dossier or responded to deficiency queries considering 1500 ng/day limit.
It will now be interesting to see if EMA also revises the limit to 100 ng/day.
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You will need to consult with the agency
Updated dashboard with recent updates from Health Canada…
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Dear Naiffer,
N-nitroso-sertraline is still has AI=1500ng/day in HC in the Dashboard
best regards
@chrischar thanks…
Dashboard updated with recent Health Canada and TGA revisions
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Hi sir, Thank you and good initiative, it’s very useful, i will share to IPA team.