It is a nitrosamine impurity that can form during the synthesis, storage, or handling of Dabigatran Etexilate, an anticoagulant medication.

Nitrosamines, including N-Nitroso Dabigatran Etexilate, are regulated by agencies like the FDA and EMA due to potential health risks.

It forms when Dabigatran Etexilate interacts with nitrosating agents, especially 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 Dabigatran Etexilate 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 Dabigatran Etexilate as a reference standard, supporting method validation, impurity analysis, and regulatory compliance.