Hello,
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@desaimayur78 you can check a great example of how the nitrate content in excipients is use to predict theoretically nitrosamine in @schlinjo1975 paper:
Back in October 2020, we saw an increased concern about the potential presence of NDMA in Metformin. @trust_user_a @trust_user_b @trust_user_c
“As of October 2020, EMA and the national competent authorities are asking marketing authorization holders for metformin-containing medicines to test their medicines before releasing them onto the market,” said EMA’s Committee on Human Medicinal Products (CHMP) in an update to its post-authorization nitrosamine impurity testing procedures”
As a Nitros…
@Yosukemino can you refer us to the post you did on the case of GSK?
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Sure, @Naiffer_Host . It reflected the strategy of EFPIA workflow ver1.0 .
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 .
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That looks like a great video overall as well. Thanks for sharing.