Quetiapine EP Impurity I (Fumarate salt)

Identification and Characterization of Potential Impurities of Quetiapine Fumarate
Elżbieta U. Stolarczyk,Łukasz Kaczmarek,Kamil Eksanow,Marek Kubiszewski,Magdalena Glice &Andrzej Kutner
Pharmaceutical Development and Technology  Volume 14, 2009 - Issue 1 Pages 29-39
 
An Improved and Single Pot Process for the Production of Quetiapine Hemifumarate Substantially Free from Potential Impurities
Navnath C. Niphade, Anil C. Mali, Bhushan S. Pandit, Kunal M. Jagtap, Sanjay A. Jadhav, Madhukar N. Jachak, and Vijayavitthal T. Mathad
Org. Process Res. Dev. 2009, 13, 4, 792–797
 
Stability indicating fast LC method for determination of quetiapine fumarate related substances in bulk and pharmaceutical formulation
R.Narendra Kumar, *G.Nageswara Rao, P.Y.Naidu
Der Pharmacia Lettre, 2011, 3(3): 457-469

Quetiapine EP Impurity I (Fumarate salt) is chemically 2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethan-1-ol fumarate (as per EP). It is also known as Quetiapine Desethoxy Impurity (USP) ; Quetiapine Alcohol Impurity ; Quetiapine Ethanol Impurity. Quetiapine EP Impurity I (Fumarate salt) is supplied with detailed characterization data compliant with regulatory guideline. Quetiapine EP Impurity I (Fumarate salt) 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 Quetiapine.

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.