This impurity is related to Dutasteride 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.
Dutasteride EP Impurity I is used as a reference standard in analytical research. It ensures consistency of formulations.
Chemical Name: (4aR,4bS,6aS,7S,9aS,9bS,11aR)-N-(2,5-Bis(trifluoromethyl)phenyl)-1-((4aR,4bS,6aS,7S,9aS,9bS,11aR)-4a,6a-dimethyl-2-oxo-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-1H-indeno[5,4-f]quinoline-7-carbonyl)-4a,6a-dimethyl-2-oxo-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-1H-indeno[5,4-f]quinoline-7-carboxamideCountry of Origin: India Product Category: Impurity Reference StandardAPI NAME: Dutasteride Molecular Formula: C46H55F6N3O4
Molecular Weight: 828
Storage: Store in a cool, dry place.