Category
Elagolix
CAS Number
2409132-60-9
Molecular Formula
C36H36F5N3O7
Molecular Weight
717.7g/mol
Synonym

4-[3-carboxypropyl-[(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-4-methyl-2,6-dioxopyrimidin-1-yl]-1-phenylethyl]amino]butanoic acid; (R)-4,4'-((2-(5-(2-Fluoro-3-methoxyphenyl)-3-(2-fluoro-6-(trifluoromethyl)benzyl)-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl)-1-phenylethyl)azanediyl)dibutyric acid

Keywords
Impurities
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.

Elagolix Dialkylated Impurity is a process impurity formed during the synthesis of Elagolix, the active ingredient in Orilissa. It occurs due to over-alkylation of an amine group and is strictly controlled within regulatory limits to ensure drug quality and safety.