New NDSRIs limits coming from EMA soon

Naiffer_Host · January 12, 2023, 11:44am

The report from Committee for medicinal products for human use (CHMP) last October reveal new limits coming for:

N-nitrosophenylephrine
N-nitrosopramipexole
N-Nitrosoreboxetine
N-nitroso-paroxetine
N-nitroso-diethanolamine
N-nitroso-mefenamic acid

Sarada.jena · January 13, 2023, 5:17am

EMA has given limits for the below Impurities in its recent Dec. '22. revision.

N-nitroso-paroxetine 1300 ng/day
N-nitroso-diethanolamine 1900 ng/day
N-nitroso-mefenamic acid 78000ng/day

Mohit · January 16, 2023, 4:25am

Last year September 2022 they have mentioned the following NDSRI:

• N-nitroso-moxifloxacin
• N-nitroso-fluoxetine
• N- nitroso-nebivolol
• N-nitroso-bisoprolol
• N-nitroso-biotin
• N-nitroso-diclofenac
• N-Nitroso-betahistine
• N-nitroso-Bupropion