This impurity is related to N-Nitroso Tulathromycin Impurity 10 is provided with comprehensive characterization data in accordance with regulatory guidelines. It is suitable for use in analytical method development, method validation (AMV), Quality Control (QC) applications for Abbreviated New Drug Applications (ANDA) and commercial production of Asenapine.
       
      
        N-Nitroso Tulathromycin Impurity 10 is used as a reference standard in analytical research. It ensures consistency of formulations.
       
      
        Chemical Name:benzyl ((2S,3R,4S,6R)-2-(((2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10-trihydroxy-13-(((3S,4S,6R,8R)-8-methoxy-4,8-dimethyl-1,5-dioxaspiro[2.5]octan-6-yl)oxy)-3,5,8,10,12,14-hexamethyl-15-oxo-1-oxa-6-azacyclopentadecan-11-yl)oxy)-6-methyl-4-(methyl(nitroso)amino)tetrahydro-2H-pyran-3-yl) carbonateCountry of Origin: India Product Category: Impurity Reference StandardAPI NAME: Tulathromycin Molecular Formula: C45H73N3O15
Molecular Weight: 896.09
Storage: Store in a cool, dry place.