Category
Osimertinib
CAS Number
1421373-99-0
Molecular Formula
C27H31N7O2
Molecular Weight
485.6 g/mol
Synonym

N-(4-methoxy-2-(methyl(2-(methylamino)ethyl)amino)-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide;

Keywords
Impurities
Metabolites.
Pharmaceutical 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.

Osimertinib N-Desmethyl impurity is a key metabolite and degradation product monitored in Osimertinib formulations to ensure drug safety, efficacy, and regulatory compliance.