Efinaconazole nitrosamine impurity

Efinaconazole nitrosamine impurity is a chemical compound that is commonly used in the pharmaceutical industry as a reference standard for the detection and quantification of impurities in Efinaconazole formulations. It is a nitrosamine derivative that is formed as a byproduct during the synthesis of Efinaconazole. Efinaconazole nitrosamine impurity is a highly reactive compound that can react with other chemicals to form carcinogenic compounds, making it an undesirable impurity in pharmaceutical formulations. Therefore, it is important to monitor and control the levels of this impurity in Efinaconazole formulations during manufacturing and storage. The chemical formula of Efinaconazole nitrosamine impurity is C18H16Cl2N6O2, and its molecular weight is 412.27 g/mol. It is a white to pale yellow crystalline powder that is soluble in organic solvents such as methanol, acetone, and ethyl acetate. Efinaconazole nitrosamine impurity is typically analyzed using high-performance liquid chromatography (HPLC) techniques coupled with mass spectrometry (MS) detection. The detection limit for this impurity is typically in the range of 0.1-0.5 ppm. In conclusion, Efinaconazole nitrosamine impurity is an important reference standard for the detection and quantification of impurities in Efinaconazole formulations. Its chemical properties and potential carcinogenicity make it an important compound to monitor and control during pharmaceutical manufacturing.