Nitrosamines were a topic of brief discussion at FDA’s FY2021 GDSR workshop earlier this week.
Sharing the powerpoints of sessions on Prevalence and Sources of Artifacts in Trace Nitrosamines Analysis in Drug Products, Developing Processes for Nitrite-Free Excipients.
Both of these topics have been under discussion & consideration amongst members of our community.
D1S10-2-Vaughn.pdf (151.5 KB)
D1S10-3-Ehlert.pdf (235.9 KB)
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Fantastic @DAB. I will post the recording as soon as FDA make them available. I will also post a couple of the concepts and ideas presented in the Workshop for the community discussion. Thanks for being in the lookout for knowledge and sharing it with the community.
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@Naiffer_Host Thankyou Naiffer, that sounds great.
I attended this workshop so thought of sharing here since we are actively discussing Excipients and this is a step ahead of the IPEC Europe session. Am still awaiting the recording from FDA, will take few days for them to make it available, till then this provides some thought process to reflect on.