Self introduction

[user2]

Hi I’m Lingaraju BS having 17 years experience in QA/QC. Currently working in Medreich R&D Bangalore for analytical QA.

[Jaime-Ivan-Ibarra]

Hello Everyone, I’m Jaime Ivan Ibarra, working for the pharmaceutical Industry, over 9 years in QA/QC area, Currently working in Bayer Mexico, collaborating with the risk assessment of nitrosamines presence in products

[Naiffer_Host]

@VQuesneau @AlanAtkins @MINALV @Sanja @Jarlath @vesna Welcome to The Nitrosamine Exchange … thanks for taking the invitation to join the community. I hope you enjoyed the experience and information shared at the ‘Genotoxic Impurities Online Summit’
I hope you bring questions, experiences, and challenges to share with our entire community.
We already started a question raised during today’s session related to the use of MW Adjustment when determining AIs values for Complex Nitrosamines.

AIs for Complex Nitrosamines by MW Adjustments, any experience?

With the recent publication of FDA’s Updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products | FDA A new concept have emerged: ‘nitrosamine drug substance-related impurities (NDSRIs)’ a class of nitrosamines sharing structural similarity to the API For this class of nitrosamines, the read-across when setting limits can be quite challenging. We have seen the case of N-nitroso-varenicline (37 ng/day). This afternoon Dr. Nudel…