Atomoxetine EP Impurity D

A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603)
Peter F. Gavin ∗, Bernard A. Olsen
Journal of Pharmaceutical and Biomedical Analysis 46 (2008) 431–441
 
Determination of the enantiomer and positional isomer impurities in atomoxetine hydrochloride with liquid chromatography using polysaccharide chiral stationary phases
Jane A. Sellers, Bernard A. Olsen ∗, Paul K. Owens, Peter F. Gavin
Journal of Pharmaceutical and Biomedical Analysis 41 (2006) 1088–1094
 
Development and validation of RP-HPLC method for the determination of Atomoxetine Hydrochloride in Pharmaceutical Dosage Forms
Gurmeet Chhabra*, Chandraprakash Jain, Saurabh K Banerjee
Int. J. Drug Dev. & Res., Oct-Dec 2011, 3 (4): 275-279

Atomoxetine EP Impurity D is chemically (3R)-N-Methyl-3-(3-methylphenoxy)-3-phenylpropan-1-amine hydrochloride (as per EP) ; (R)-N-Methyl-3-phenyl-3-(3-tolyloxy)propan-1-amine hydrochloride (as per USP). It is also known as Atomoxetine USP Related Compound B ; m-Methyl Atomoxetine HCl. Atomoxetine EP Impurity D is supplied with detailed characterization data compliant with regulatory guideline. Atomoxetine EP Impurity D can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Atomoxetine .

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.