Any ideas of why EMA has a limit for nitroso-methylphenidate but not FDA? Below is the methylphenidate structure. I’ll admit, I’m at a loss.
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Dear @jason.brown. Not only N-nitroso Methylphenidate. There are others few where FDA and EMA have slight differences or un-attendance.
I think AI of 1300 ng/day is fair enough for that. If still that does not serve purpose, you may go for detailed SAR analysis.
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Thanks. That’s what I was thinking too. To me, it looks like the limit should be 1500 ng/day based on the new scoring system. I just think it’s really odd that it is not included.
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There are several nitrosamines that EMA has mentioned but FDA has not. Some of them are rather simple ones. If you notice the three nitrosamines that were found non-carcinogenic are not mentioned in FDA guidance. There are a lot of legal implications in US and they are treading carefully.
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Interesting. Thank you for that insight.
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