Managing Nitrite Impurities: A Combined Supplier-Manufacturer View to Nitrosamine Risks

Events / Workshops / Webinars
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You do not want to miss this webinar with the participation of @schlinjo1975 and @Ulrich on Sep 28th

Description:
The presence of nitrites in excipients evolved as a hot topic among regulatory agencies across the world. This Nitrites in excipients are seen as a risk factor to form nitrosamines in the presence of vulnerable amines during drug product manufacturing process and storage. Health Authorities worldwide imposed recalls to drug products. Our data indicate that the presence of nitrosamines in pharmaceuticals is likely more prevalent than originally expected. This webinar will review the current regulatory considerations, the role of nitrites, the analytical controls. The view of a drug product manufaturer on the related risk mitigation strategy and a case study on risk mitigation is presented.

Free Registration: Managing Nitrite Impurities: A Combined Supplier-Manufacturer View to Nitrosamine Risks

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The presentation concerning the training mentioned above is included for your reference. This training proved highly beneficial, and I would like to extend my gratitude to @Naiffer_Host for providing the link to attend the meeting.
nitrite-webinar-presentation-slides.pdf (4.6 MB)

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Thank you for sharing the slides, @Sarada.jena. It’s fantastic. I want to focus on the Categories used on EMPROVE. If those data are available, it’s quite helpful to understand the contamination risk of NDSRIs. I love it!! :smile:

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I believe it is critical to highlight that many excipient suppliers are doing a fantastic job supporting their customers when it comes to providing data for risk assessment, as well as modifying their manufacturing processes to accommodate lower concentrations of nitrates.

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