Is there any possibility to generate the N-Desmethyl Tramadol in formulation?

Limits of Nitrosamines
1

Dear All.
is there any possibility to generate the N-Desmethyl Tramadol Impurity in formulation?
if yes, how to control the generation of Desmehylation of Tramadol.
Thank you in advance.

2

Dear Harshad,
although is consider difficult to have demethylation in a solid form, you cannot exclude this. We have seen a demethylation to one of our products during stability (not tramadol, other API). So, you should perform a confirmatory test in your formulation, at least at ACC conditions for the identification of N-nitrosodesmethyl tramadol. If its quantity is <10% then you will not have to worry about the demethylation process.
If you want to control the demethylation, i would propose to take care from oxidative or photolytic factors, as demethylation is usually result of oxidation or photodegradation.

Christos

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3

Thank you for your response.

4

suggest conducting confirmatory testing