This impurity is related to Atripla 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.
Atripla is used as a reference standard in analytical research. It ensures consistency of formulations.
Chemical Name:Fumaric acid compound with (R)-(((((1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)phosphoryl)bis(oxy))bis(methylene) diisopropyl bis(carbonate) and (S)-6-chloro-4-(cyclopropylethynyl)-4-(trifluoromethyl)-1,4-dihydro-2H-benzo[d][1,3]oxazin-2-one and 4-amino-5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one (1:1:1:1)Country of Origin: India Product Category: Impurity Reference StandardAPI NAME: Atripla Molecular Formula: C14H9ClF3NO2 : C8H10FN3O3S : C19H30N5O10P : C4H4O4
Molecular Weight: 315.2 : 247.2 : 519.5 : 116.1
Storage: Store in a cool, dry place.