Would like to understand about Risk Assessment strategies being employed for Nitrosamines evaluation in Primary Packaging Materials.
Are there any Formal methods , acceptance criteria as yet established wrt Nitrosamine control in Pharmaceutical Excipients & Primary Packaging Materials.
Request members to share their views/experience.
Thanks @DAB. Have you had chance to watch we posted on this topic lead by @AndyTeasdale and @areumer They both discussed great case studies. In the presentation Andrew mentioned Volatilization of Nitrosamines trapped in the blister pocket during sealing, work done by Novartis. Not sure if this is published thought. Maybe @Founding_Expert’s colleague from Novartis that we could invite to the community to share additional information?
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Hi @Naiffer_Host ,
Thanks for sharing, that was an excellent session, more food for thought!
Hi,
Is there any possibillity of Nitrosamine impurity from quaternary ammonium compounds like Benzalkonium chloride (Alkyl dimethyl benzyl ammonium chloride)?
Here are some references on packaging materials:
- Nitrocellulose Blister Material as a Source of N-nitrosamine Contamination of Pharmaceutical Drug Products (Golob et al., Int. J. Pharmaceutics, 2022)
- Evaluating Nitrosamines from Elastomers in Pharmaceutical Primary Packaging (Boltress, PDA J. Pharm Tech Sci., 2021)
- On the Risk of Nitrosamine Contamination During Drug Product Blister Packaging (J. Zheng et al., J.Pharm.Sci., 2023)
- https://www.efpia.eu/media/676632/efpia-nitrosamines-quality-risk-management-workflows-sep-2022.pdf
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I noticed that this question hasn’t been answered yet, and I was wondering if there are any updates or insights regarding it.
@Naiffer_Host , do you perhaps have any information on this?