Apixaban Drug Substance-Related Impurities (NDSRIs)

Dear Nitrosamines enemies,

Is there any known NDSRIs for Apixaban? Have you faced any of them in your projects or came across in a publication or a presentation?
If there is no knwon NDSRIs, what is the proper method to identify possible NDSRIs?
Thanks for your usual support.


My advice would be to go through all related substances, both process impurities from the manufacturing process of the API, including intermediates, and degradation impurities at API and finished product level. If you spot a secondary amine (none are present in the structure of Apixaban), you would have a precursor of a NDSRI. I would specially look for hydrolysis products of those amides, which could lead to secondary amines


Hi, @Alaaelkazak.

You can find pharmacopeial and non-pharmacopeial impurities of Apixaban in the following URL.

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Please refer to the Global Substance Registration System (GSRS) / Impurities section, where 10 impurities associated with the API are reported. (NIH/FDA/USP)