Nitrosamines from polybags to finished product

Root Causes Packaging
1

HI,

I want to discuss about nitrosamines from Polybags. Can Nitrates/amines will be available in poly bags and transfer to API/Finished product during the storage. I have asked couple of vendors for the declaration, but they cannot arrange for it.
So, do we need to consider the risk from polybags also?

Thank you…

2

This has been discussed previously here…

Anybody inquired about Nitrosamines in Poly bags? - Risk Assessment Strategy / Tools & Technology - Nitrosamines Exchange (usp.org)

But it is something that has never been completely closed off.

Different packaging material results are also reported in the following, but it isn’t open access, so you will need to pay to be able to read. Not all packaging materials are covered, but it does give a good indication.

https://jpharmsci.org/article/S0022-3549(24)00017-0/fulltext

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Thanks Mark… in the article i couldn’t find about the polybags.
Evaluation of a Novel LC-MS_MS Based Analytical Method for the Risk Assessment of Nitrosamines in Pharmaceutical Products and Packaging Materials - ScienceDirect.pdf (214.9 KB)

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This is true - it doesn’t mention poly bags, but there are packaging types included that are LDPE and HDPE I believe - there is nothing conclusive, but it is a good indicator towards your risk assessments.

Nelson labs have presented at conferences in the past on nitrosamines and packaging - @Naiffer_Host - do you know if we are OK to share the presentation from the Amsterdam conference?

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Thank you Mark!
There is a Youtube video https://www.youtube.com/watch?v=1QGsnJH7uIQ
and some on-demand webinars Primary and Secondary Packaging Materials as potential source of Nitrosamines: impact on E&L Study design - Nelson Labs
and
N-Nitrosamines in Primary Packaging for SVP’s

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