2476859-55-7N-Nitroso Ticagrelor; Synthesis Attempts and Failure Report (NAP Test)

N‑Nitroso Ticagrelor is a proposed nitrosamine impurity related to ticagrelor, a P2Y12 receptor antagonist (antiplatelet agent). It may arise through nitrosation of a nitrogen‑containing heterocycle/amine within the molecule or related intermediates when exposed to nitrosating agents (e.g., nitrite), typically under acidic conditions.

EMA Guidance on Nitrosamines

According to EMA guidelines, if repeated synthesis attempts fail to detect the formation of nitrosamine impurities, it is likely that the impurity either does not exist or poses an extremely low risk.

Nitrosation

We conducted multiple nitrosation assays under rigorous forced conditions (NAP tests), to evaluate the risk of N-Nitroso Ticagrelor formation. Our findings revealed that N-Nitroso Ticagrelor does not readily undergo nitrosation under the expected conditions, significantly reducing concerns about its potential formation.

Request Synthesis Failure Report Quote

Our synthesis failure report provides a detailed account of the findings from our synthesis attempts and rigorous testing, demonstrating the non-formation of the nitroso impurity. It offers a comprehensive overview of the evaluated conditions and the resulting data.

N-Nitroso Ticagrelor Technical Information

• Molecular Weight: 551.6 g/mol
• Molecular Formula: C23H27F2N7O5S
• IUPAC Name: N-((1R,2S)-2-(3,4-difluorophenyl)cyclopropyl)-N-(3-((1R,2S,3S,4S)-2,3-dihydroxy-4-(2-hydroxyethoxy)cyclopentyl)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-7-yl)nitrous amide
• CAS Number: 2476859-55-7
• Synonyms: N/A

Need a Sample Synthesis Failure Report? Contact us