Finasteride NDSRI

Limits of Nitrosamines
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1

Dear everyone

I am currently conducting a nitrosamine risk assessment for finasteride-containing products in accordance with the latest regulatory requirements from EMA, FDA, and ICH M7(R2). As part of this evaluation, I am seeking to gather comprehensive information and reference materials specifically related to N-nitroso-finasteride as a potential nitrosamine drug substance-related impurity (NDSRI).

I would greatly appreciate it if you could share any of the related materials.

2

Hi

Please note that Finasteride cannot form nitrosamines, only potentially a nitrosamide (if at all)

3 Likes
3

Hi

Thank you for your clarification about nitrosamide for Finasteride.