CAT. No. | CP-E9001 |
---|---|
CAS. No. | NA |
Mol. F. | C32H29F5N4O6 |
Mol. Wt. | 660.60 |
Stock Status | In Stock |
It is a nitrosamine impurity that can form during the synthesis, storage, or handling of Elagolix, a medication used to manage endometriosis and uterine fibroids.
Nitrosamines, including N-Nitroso Elagolix, are regulated by agencies like the FDA and EMA due to potential health risks.
It forms when Elagolix interacts with nitrosating agents, particularly under conditions involving heat, moisture, or acidity.
Formation can be managed by controlling storage conditions, managing pH levels, and conducting routine testing.
Advanced analytical methods such as GC-MS, LC-MS, and HPLC-MS are used for precise detection and quantification.
Chemicea supplies COA, H-NMR, MASS, HPLC, and TGA reports as standard, with additional reports like CNMR, IR, UV, DEPT, Water content, and CHNS available upon request.
Yes, they meet standards required by major agencies such as USFDA, EMA, ANVISA, TGA, PMDA, and others.
N-Nitroso Elagolix is stable for shipping at room temperature, with specific storage guidelines provided in the COA.
Yes, both standard and customized pack sizes are available to meet specific client needs.
Chemicea provides N-Nitroso Elagolix as a reference standard, supporting method validation, impurity analysis, and regulatory compliance.