This impurity is related to Clarithromycin EP Impurity I 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.
Clarithromycin EP Impurity I is used as a reference standard in analytical research. It ensures consistency of formulations.
Chemical Name:(3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-6-(((2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-14-ethyl-4,12,13-trihydroxy-7-methoxy-3,5,7,9,11,13-hexamethyloxacyclotetradecane-2,10-dioneCountry of Origin: India Product Category: Impurity Reference StandardAPI NAME: Clarithromycin Molecular Formula: C30H55NO10
Molecular Weight: 589.76
Storage: Store in a cool, dry place.