Can Activated carbon promote nitrosamine formation and lead to high Nitrosamine levels in FP?

Dear community

I am not aware whether this topic has been raised previously, but let me share with you a concern of mine.
We are under evaluation of a new supplier. We observe that they use AC in the final synthetic step. In literature it is discussed that AC can catalyze nitrosamine formation (but the articles are more environment-oriented).

Although they have not reported high nitrosamine values in finished API, we observe high nitrosamine values in finished product.
Since we keep all rest factors same (manufacturing process, excipients, packaging etc), do you trust that we may notice high nitrosamine levels in FP especially considering that the yield of nitrosamine formation may be much higher with nitrite (trace nitrite levels found in excipients)?

If all the above is true, could you please recommend any alternative to AC?

Thank you for your time :slight_smile:

Hi Eleni,
Based on the literature, Active Carbon is not a probable risk factor in generating Nitrosamines, when used in the purification steps of the APIs.
The nitrosamine formation in FP cannot be related to the use of active carbon in the API synthesis.

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Hi
thank you for your kind response. Would you please be so kind to share the reference with me?
:slight_smile:

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Hi Eleni,
usually AC is used for the purification of the organic compounds and from organic chemistry point of view is considered very difficult to be present as a residual or impurity in the β€˜β€˜pure’’ compound.
May i ask you, the high levels of nitrosamine(s) you noticed in the final product are related to a NDSRIs or to nitrosamine(s) which are not related with the API?
kind regards

Hi Christos!
hope you are doing well! thank you for your response!

we are talking about an NDSRI found in API and in FP.

As for AC, since I am not so familiar with chemistry point of view, your feedback is appreciated. I am just wondering whether it could be potentially act in a way that enhances the yield of NDSRI in API and subsequently in API during storage.
Mostly, because rest reagents/ solvents are pretty much common among the two suppliers.

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If the route of synthesis is not the same, or even if it is the same, the source of reagents/solvents can lead to different levels of nitrites, which consequentially can lead to different levels of NDSRI.
If AC is a possible concern, try testing both API, same batch, prior and after AC

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