Aripiprazole EP Impurity G

Formulation of aripiprazole-loaded pH-modulated solid dispersions via hot-melt extrusion technology: In vitro and In vivo studies
Haley McFall1 , Sandeep Sarabu1 , Vijaykumar Shankar1 , Suresh Bandari1 , S. Narasimha Murthy1 , Karl Kolter2 , Nigel Langley3 , Dong Wuk Kim4**, Michael A. Repka
International Journal of Pharmaceutics Volume 554, 10 January 2019, Pages 302-311
 
Molecular determinants of the intrinsic efficacy of the antipsychotic aripiprazole
Carmen Klein Herenbrink, Ravi Verma, Herman D Lim, Anitha Kopinathan, Alastair Keen, Jeremy Shonberg, Christopher J. Draper-Joyce, Peter J. Scammells, Arthur Christopoulos, Jonathan A Javitch, Ben Capuano, Lei Shi, and J Robert Lane
ACS Chem. Biol. 2019, 14, 8, 1780–1792
 
Identification of Degradation Impurities in Aripiprazole Oral Solution Using LC-MS and Development of Validated Stability Indicating Method for Assay and Content of Two Preservatives by RP-HPLC
M. V. V. N. Murali Krishna, Sumathi V. Rao & N. V. S. Venugopal
European Journal of Chemistry 2010, 1(1), 20-27
 
Development of stability indicating, validated HPLC method for quantitative determination of Aripiprazole and its impurities
Nandini R. Pai*, Deepnandan S. Dubhashi
Der Pharmacia Lettre, 2010, 2(4): 1-10

Aripiprazole EP Impurity G is chemically 7,7′-[Ethane-1,1-diylbis[(2,3-dichloro-4,1-phenylene)piperazine-4,1-diylbutane-4,1-diyloxy]]di(3,4-dihydroquinolin-2(1H)-one) (as per EP) ; 1,1′-(Ethane-1,1-diyl)bis(2,3-dichloro-4-{4-[3,4-dihydroquinolin-2(1H)-one-7-yloxybutyl]piperazin-1-yl}benzene) (as per USP). It is also known as Aripiprazole 4 4'-dimer (USP). Aripiprazole EP Impurity G is supplied with detailed characterization data compliant with regulatory guideline. Aripiprazole EP Impurity G 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 Aripiprazole.

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.