This impurity is related to Gamithromycin Impurity 4 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.
Gamithromycin Impurity 4 is used as a reference standard in analytical research. It ensures consistency of formulations.
Chemical Name:N-((2S,3S,4S,6R)-2-(((2R,3S,4R,5S,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10-trihydroxy-13-(((2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy)-3,5,8,10,12,14-hexamethyl-15-oxo-7-propyl-1-oxa-7-azacyclopentadecan-11-yl)oxy)-3-hydroxy-6-methyltetrahydro-2H-pyran-4-yl)-N-methylformamideCountry of Origin: India Product Category: Impurity Reference StandardAPI NAME: Gamithromycin Molecular Formula: C40H74N2O13
Molecular Weight: 791.02
Storage: Store in a cool, dry place.