Estimation of Nitrosamines from Nitrites level

[Yosukemino]

Sure, @Naiffer_Host. It reflected the strategy of EFPIA workflow ver1.0.

Lactose, Nitrosamine Risk?

I share the good example of nitrite calculation contained in excipients and others demonstrated by Dr. Urquhart in nitrosamine workshop last week. [nitrite in excipient] According to him, contamination risk is evaluated with 100% conversion at first. Next a conversion factor, whose detail is not included here, is considered and the calculated value is compared with (adjusted) ADI. This example may concern with API with secondary or tertiary amine, however if the amount of these amines is at …

And I add the link to the relevant section on Vimeo. I hope it will help you, @desaimayur78.