Category
Elagolix
CAS Number
NA
Molecular Formula
C32H28F5N4NaO6
Molecular Weight
682.6 g/mol
Synonym

Sodium (R)-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)(nitroso)amino)butanoate

Keywords
Impurities
N-Nitrosamines Impurities manufacturers and Suppliers in Hyderabad India
slide.1
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.

N-Nitroso Elagolix Impurity 1 is a nitrosamine-related impurity that may form during the synthesis or storage of Elagolix. Nitrosamine impurities are strictly regulated due to their potential genotoxic or carcinogenic risk, so this impurity must be identified, quantified, and controlled according to regulatory safety guidelines to ensure drug quality and patient safety.