Category
Abemaciclib
CAS Number
NA
Molecular Formula
C₂₅H₂₇F₂N₉O
Molecular Weight
507.55 g/mol
Synonym

N-Nitroso Abemaciclib ; 5-Fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)-N-(5-((4-nitrosopiperazin-1-yl)methyl)pyridin-2-yl)pyrimidin-2-amine ; Abemaciclib Nitroso Metabolites M2 ;

Keywords
Intermediates
Fine Chemicals
Metabolites.
Pharmaceutical Standards
Impurities
Impurities manufacturer and Suppliers in Hyderabad india
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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Abemaciclib Piperazine Nitrosamine Impurity refers to a nitrosated derivative formed from the piperazine ring present in abemaciclib. It is typically generated when secondary amine groups in the piperazine moiety react with nitrosating agents (e.g., nitrites) during manufacturing or storage, forming N-nitrosopiperazine-type impurities, which are potentially genotoxic and must be controlled at trace levels per regulatory guidelines.