This impurity is related to Spiramycin EP Impurity E 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.
Spiramycin EP Impurity E is used as a reference standard in analytical research. It ensures consistency of formulations.
Chemical Name:(4R,5S,6S,7S,9R,10R,11E,13E,16R)-6-[[3,6-dideoxy-4-O-(2,6-dideoxy-3-C-methyl-a-l-ribo-hexopyranosyl)-3-(dimethylamino)-?d-glucopyranosyl]oxy]-7-ethyl-4-hydroxy-5-methoxy-9,16-dimethyl-10-[[2,3,4,6-tetradeoxy-4-(dimethylamino)-?d-erythro-hexopyranosyl]oxy]oxacyclohexadeca-11,13-dien-2-one (18-deoxy-18-dihydrospiramycin I or DSPM)Country of Origin: India Product Category: Impurity Reference StandardAPI NAME: Spiramycin Molecular Formula: C43H76N2O13
Molecular Weight: 829.1
Storage: Store in a cool, dry place.