Category
Elagolix
CAS Number
2248628-93-3
Molecular Formula
C32H28F5N3O4
Molecular Weight
613.6g/mol
Synonym

(R)-5-(2-Fluoro-3-methoxyphenyl)-1-(2-fluoro-6-(trifluoromethyl)benzyl)-6-methyl-3-(2-(2-oxopyrrolidin-1-yl)-2-phenylethyl)pyrimidine-2,4(1H,3H)-dione; 5-(2-fluoro-3-methoxyphenyl)-1-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-6-methyl-3-[(2R)-2-(2-oxopyrrolidin-1-yl)-2-phenylethyl]pyrimidine-2,4-dione

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 Lactam Impurity is a degradation-related impurity of Elagolix, the active ingredient in Orilissa. It forms through intramolecular cyclization, leading to the creation of a lactam (cyclic amide) structure. This impurity is identified, characterized, and controlled within specified limits to maintain the drug’s safety, stability, and quality.