Ribociclib Succinate NDSRIs limit clarification related

Ribociclib Succinate drug substance would like to inform you that,. On January 15, 2024, EMA has published Appendix-1, EMA/25140/2024/Rev.2 and mentioned AI 400 (ng/day) in Appendix-1 for "Ribociclib Succinate Nitrosamine Impurity I (7-cyclopentyl-N,N-dimethyl-2-((5-(4-nitrosopiperazin-1-yl)pyridine-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide)”.

In other hand on January 15, 2024, EMA has published Q & A EMA/409815/2020 Rev.20 mentioned as “For products intended for advanced cancer only as defined in the scope of the ICH S9 guideline, nitrosamine impurities should be controlled according to ICH Q3A(R2) and ICH Q3B(R2) guidelines, as specified in the Q&A document to ICH S9 guideline”.

We request to you provide the clarity on Ribociclib Succinate NDSRIs limit, can we adopt ICH Q3A(R2) as per Q & A EMA/409815/2020 Rev.20 or AI 400 (ng/day) as per Appendix-1, EMA/25140/2024/Rev. 2.

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I hope this message finds you well. I wanted to follow up on our my concern regarding [ [Ribociclib Succinate NDSRIs limit clarification related]
Please let me know your thoughts on the above said points.

I look forward to hearing from you soon.

Best regards,
Kapil Vaja

Hi Kapilvaja,

Do you have any analytical methods of Ribociclib succinate NDSRI ?

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