Excipients, morpholine?

One question to all excipient-experts: Have you heard about morpholine-“impurities” in excipients, such as e.g. fatty acids and so? I heard something and just wanted to ask the experts, as I have no idea about excipients and their production process. Can this come from the production process? I read on google :slight_smile: that morpholine can be used as a neutralizing agent, don’t know if this is such a reliable source though :-). Thanks for your thoughts,

It’s interesting. I only found the example of morpholine fatty acid salt commonly used as food additive to protect citrus fruit against deterioration. Though morpholine is used for many purposes such as the production of API, dyes, optical brighteners, waxes/resins for food and paper coatings, polishes, rubber-processing chemicals, and corrosion inhibitors for boiling waters, excipients are free from morpholine in many cases, I think.

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Morpholine is not active on genotoxicity or carcinogenicity in PubChem. Do I need to make a regulation on it?

Yes, not morpholine as such, but it can react to form N-Nitrosomorpholine, NMOR, which is one of the targeted nitrosamines.

Ok, yes, I googled it as well, but couldnt find anything on excipients either. So, I guess it is less about the excipients but rather about the API production and water supply.
Thanks, and any other ideas are welcome here as well.