N-nitrosodicyclohexylamine (NDCHA), what do you know about it?

Limits of Nitrosamines
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Hello everyone,

In a brief search I could not get information about the limit and carcinogenic potency of the NDCHA nitrosamine.
So, I’m very pleasure if the community can help me about N-nitrosodicyclohexylamine nitrosamine, I mean, if already there is an acceptable intake established for this impurity? Or we need apply CPCA categorization or adopt 1,5 ug/day by ICH?
Please, provide the references for this topic.

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Hi @CesarJr,
There is no established AI limit for N-Nitrosodicyclohexylamine in EMA, U.S FDA and Health Canada Appendix list. Further, no robust carcinogenicity data is available in the LCDB database. Hence, the only option is to apply CPCA - Potency Category 5 - 1500 ng/day.

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Hi @Sushant!
Many thanks for the reply… There really is a shortage of references for the discussion of this nitrosamine.
I appreciate your help.
If there is someone who would like to contribute to the discussion too, please, feel free for do that.

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There are some good surrogates of this, which you may want to look into.

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Hi:
Оne of the ways is CPCA analysis, article that can help you is below:
Determining Recommended Acceptable Intake Limits for N-nitrosamine Impurities in Pharmaceuticals_ Development and Application of the Carcinogenic Potency Categorization Approach _ FDA.pdf (241.0 KB)
You can use <1,5 ug/day limit for nitrosamine impurity, if Ames test in vitro is negative for that impurity. If Ames test is negative in vitro and in vivo, you can use limit of guideline ICH3B.
I am happy , if I can help you.

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Or if in the result of CPCA analysis potential category of impurity is 5.

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