Category
Asciminib
CAS Number
NA
Molecular Formula
C₂₀H₁₆ClF₂N₅O₃
Molecular Weight
447.82 g/mol
Synonym

N-(4-(Chlorodifluoromethoxy)phenyl)-6-(3-oxopyrrolidin-1-yl)-5-(1H-pyrazol-5-yl)nicotinamide;-[4-[Chloro(difluoro)methoxy]phenyl]-6-(3-oxopyrrolidin-1-yl)-5-(1H-pyrazol-5-yl)pyridine-3-carboxamide; Asciminib Impurity 52

Keywords
Metabolites.
Pharmaceutical Standards
Intermediates
Fine Chemicals
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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.

Asciminib keto impurity refers to a chemical degradation or synthetic by-product in which a ketone functional group forms unintentionally during manufacturing or storage. This impurity can affect the purity, stability, and safety of the drug, so regulatory guidelines and pharmacopeial standards require its identification, quantification, and control to ensure the final product meets quality specifications for clinical use in Chronic Myeloid Leukemia.