Hello everyone,
Has anyone studied “1-Nitroso-moxonidine Impurity 3” and “1-Nitroso-moxonidine”, which are listed in the EMA with both of acceptable intake value of 553 ng/day?
Thank you in advance for your answers.
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These impurities are very much possible and need to show its control by monitoring during process and stability.
Actually, these impurities have same mass transitions and retention time. We tried lots of columns and mobile phases (fluoro-phenyl, phenyl-hexyl, PFP column, BEH AX; acidic and basic mobile phases). We couldn’t find anything distinctive.
What would you recommend in situations like this? I’m curios about different opinions.