This impurity is related to Azithromycin Dihydrate 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.
Azithromycin Dihydrate is used as a reference standard in analytical research. It ensures consistency of formulations.
Chemical Name:(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-a-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-?D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one dihydrate ; (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-a-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-?d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one dihydrate (as per USP)Country of Origin: India Product Category: Impurity Reference StandardAPI NAME: Azithromycin Molecular Formula: C38H72N2O12 : 2H2O
Molecular Weight: 749.0 : (18.0)
Storage: Store in a cool, dry place.