This impurity is related to N-Nitroso Josamycin Impurity A 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 Josamycin Impurity A is used as a reference standard in analytical research. It ensures consistency of formulations.
Chemical Name:(2S,3S,4R,6R)-6-(((2R,3S,4R,5R,6S)-6-(((4R,5S,6S,7R,9R,10R,11E,13E,16R)-4-acetoxy-10-hydroxy-7-(2-hydroxyethyl)-5-methoxy-9,16-dimethyl-2-oxooxacyclohexadeca-11,13-dien-6-yl)oxy)-5-hydroxy-2-methyl-4-(methyl(nitroso)amino)tetrahydro-2H-pyran-3-yl)oxy)-4-hydroxy-2,4-dimethyltetrahydro-2H-pyran-3-yl 3-methylbutanoateCountry of Origin: India Product Category: Impurity Reference StandardAPI NAME: Josamycin Molecular Formula: C41H68N2O16
Molecular Weight: 845
Storage: Store in a cool, dry place.