Category
Elagolix
CAS Number
NA
Molecular Formula
C32H29F5N4O6
Molecular Weight
660.6 g/mol
Synonym

(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)butanoic Acid

Keywords
Intermediates
Impurities
Metabolites.
Pharmaceutical Standards
Fine Chemicals
Nitrosamine Standards manufacturers and Suppliers in Hyderabad India
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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 Nitroso Impurity is a potential nitrosamine-related impurity that can form during the manufacture or storage of Elagolix. Nitroso impurities are closely monitored because some nitrosamines may pose carcinogenic risks. Therefore, strict regulatory guidelines require their identification, risk assessment, and control to ensure the safety and quality of the drug product.