Aprepitant EP Impurity C

Application of analytical quality by design principles for the determination of alkyl p-toluenesulfonates impurities in Aprepitant by HPLC. Validation using total-error concept
Constantinos K. Zacharis, Elli Vastardi
Journal of Pharmaceutical and Biomedical Analysis Volume 150, 20 February 2018, Pages 152-161
 
Characterization and Quantitation of Aprepitant Drug Substance Polymorphs by Attenuated Total Reflectance Fourier Transform Infrared Spectroscopy
Roy Helmy,* George X. Zhou, Yadan W. Chen, Louis Crocker, Tao Wang, Robert M. Wenslow, Jr., and Anant Vailaya*
Anal. Chem. 2003, 75, 605-611
 
Development and Optimization of Liquid Chromatography Analytical Methods by Using AQbD Principles: Overview and Recent Advances
Tim Tome,†,Nina Ž igart, Zdenko Č asar,, and AlešObreza
Org. Process Res. Dev. 2019, 23, 1784−1802
 

Aprepitant EP Impurity C is chemically 5-[[(2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4′-fluorobiphenyl-4-yl)morpholin-4-yl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one ( as per EP). It is also known as Aprepitant para-Biphenyl Impurity ; 4-Defluoro-4-(p-fluorophenyl)aprepitant. Aprepitant EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Aprepitant EP Impurity C 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 Aprepitant.

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.