Indigo carmine as secondary amine?

Root Causes Excipients
1

Dear all,

How would you consider indigo carmine structure, as a secondary amine? or as a oxoindole instead (which consequently, is outside of the scope of nitrosamine guidelines)?
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Thanks in advance for your collaboration,
Victoria

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2

The same applies as for imidazole

3

Again, thanks so much!

4

We tried to synthesize nitrosamine intentionally but could not form nitrosamine.

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5

Two nitrosamines of Indigo Carmine is possible;
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6

This is an indole and nitroso indoles and some nitroso indoles are carcinogenic. But again, we can consider the technicality of the fact that this is not a ā€œnitrosamineā€. So, while at some point you need to look into this, may be the deadlines do not apply to this.

Again, agencies have been absolutely silent on this issue on N-nitroso compounds vs nitrosamines. I am tryng to help prioritize the risks mitigation.

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7

Thanks for you feedback!
ThatĀ“s true, it is not a ā€œnitrosamineā€. this structure should be revised on an ICH M7 assessment but may be not on an nitrosamine risk assessment.
kind regards,
Victoria

8

Thanks for your feedback!